Lecture: What You Should Know About CJC-1295 with Ipamorelin, PT-141 also known as Bremelanotide, and BPC-157

 

TRANSCRIPT

Good afternoon, everyone, and thank you for joining us for today’s webinar on some new products being offered by Wells Pharmacy Network. We’re going to talk about three new items: CJC-1295 with Ipamorelin, PT-141 also known as Bremelanotide, and BPC-157. My name is Ken Pettengill, and I’m one of the compounding pharmacists here at Wells Pharmacy Network.

We will include some background and rationale for each of these products. Specifically, we will review the effects of growth hormone decline with aging. We’ll review male erectile dysfunction and female sexual dysfunction. We’ll go over the new products, CJC-1295 with Ipamorelin, PT-141 and BPC-157, and how they can help with these issues. We’re going to talk about dosing, some common side effects and how they’re offered for your patients. Then we will wrap up and take any questions that you might have.

Let me first say that we’ve already posted sermorelin webinar on our YouTube page that does a good job reviewing the physiological processes, how growth hormone is released and how it declines with age. I won’t go overall that again. I will say that growth hormone is secreted by the anterior pituitary and released into the bloodstream in an intermittent or pulsatile manner. Up to eight to 10 pulses of growth hormone are secreted in a 24-hour period. We also know that the majority of growth hormone secretion occurs during deep sleep.

I’ve listed some of the benefits of growth hormone secretion during the early morning hours, benefits such as improved sleep, increased exercise capacity, increased bone density, increased muscle mass and strength, and decreased body fat. Add cognitive benefits include improved cognition and mental function and decreased anxiety and depression. The theory is that growth hormone replacement to restore optimal concentrations may improve and sustain a youthful anatomy and physiology and thus good health and vitality during aging. This all leads to an improvement in quality of life.

Here’s the simple graphic illustration of the declining growth hormone with age. It shows the total amount of growth hormone secreted per day versus age in years. You will note that growth hormone secretion is highest around puberty and after age 20 to 30, it declines progressively to about 14 to 15% every 10 years.

Little water break. Here we have another graph, which shows the pattern of growth hormone secretion in younger and older women and men. Again, we see age-related decline in growth hormone secretion for both sexes with a notable loss of enhanced growth hormone secretion typically seen during deep sleep. We can also see that growth hormone secretion is higher in women than in men, but this difference is no longer detectable after about age 50.

So what are some of the signs of growth hormone deficiency? We might see a decrease in lean muscle mass, a decrease in bone density. We might see increased fat mass, especially around the waist and abdomen. We might see a loss of skin elasticity, and we might also see slow recovery from injuries. Additional signs of growth hormone deficiency include hair loss and atherogenic lipid profile or dyslipidemia, impaired glucose tolerance and insulin resistance, increased anxiety and depression, and cognitive impairment. I should also mention fatigue.

This leads us to treatments for growth hormone deficiency. The obvious choice seems like administering actual human growth hormone, but there are problems with this. Improper dosing can lead to side effects. There are long-term risks that include fluid retention, joint/muscle pain, and high blood pressure. Improper dosing can also lead to metabolic risk such as diabetes. There’s also some evidence that growth hormone could be mitogenic leading to uncontrolled growth and tumor formation. These studies also show possible increased risk of… Hold on please. May increase risk of lung and colon cancer amongst others.

Sorry. So sorry, I’ll be right back. So sorry about that. Finally, injecting growth hormone creates unnatural conditions of exposure. Some people think that the body responds best to growth hormone when it is released in a pulsatile fashion. Daily injections of growth hormone might erode this normal response leading to tachyphylaxis and reduced efficacy.

A better treatment for growth hormone deficiency might be replacement with growth hormone-releasing hormone. This would allow for more natural pulsatile release of growth hormone rather than the prolonged exposure seen with actual growth hormone injection. This more accurately reflects the normal physiological actions of growth hormone and prevent supraphysiological exposure that might lead to tachyphylaxis and reduced response. This would also allow for normal feedback regulation by IGF-1 and somatostatin, which can offer some protection against potential growth hormone overdose. So let’s talk about some of these growth hormone-releasing hormones.

The first is actual growth hormone-releasing hormone. This is a 44-amino acid neuropeptide secreted by the hypothalamus that stimulates the synthesis and release of growth hormone from the pituitary. It has also been shown to help promote slow-wave sleep. As a therapy for growth hormone replacement however, it has the drawback of a very short half-life only seven minutes or so. An improvement on this is GRF (1-29) also known as sermorelin. This is a 29-amino acid peptide, which is a fragment of, oops [inaudible 00:07:02], which is a fragment of GHRH. This is the shortest fully functional fragment, which retains full activity. The half-life is a little better than actual GHRH around 13 minutes.

Okay. A further improvement on sermorelin is one of the new products we offer called CJC-1295, also known as modified GRF (1-29). This is a tetrasubstituted analog sermorelin. It contains the full biological activity of GHRH and has been modified by the substitution of four amino acids that makes the compound more resistant to proteolytic cleavage or breakdown. The half-life is even better around 30 minutes.

The first figure on this page shows the 29-amino acid sequence for CJC-1295 and the substitutions, which are numbered and highlighted in bold. Specifically, we see a D-alanine at the two-position, a glycine at the eight-position and alanine at the 15-position and a leucine at the 27-position. The benefits of these substitutions are listed on the figure. I’ve also provided the chemical structure of CJC-1295 as an FYI.

In the interest of full disclosure, I’m including a picture of another version of CJC-1295 that which just combined with the drug affinity complex. This is CJC-1295 connected by a lysine linker to maleimidopropionic acid. This ration binds with serum albumin and has an extended half-life of around eight days. However, we do not offer this version. Instead, we offer the CJC-1295 without drug affinity complex. Its half-life of 30 minutes or so should be more than adequate if used at bedtime. This is because GHRH pulses only last up to 30 minutes before the body has used up the potential benefit of that pulse. We’ve already seen that the single biggest GH pulse occurs during sleep. CJC-1295 without DAC also allows for a more pulsatile release of growth hormone similar to the GH release seen in response to GHRH. I will mention if you read about this online, some sites will say that CJC-1295 without DAC provides a more effective GH spike during sleep and that this prevents something referred to as GH bleed. I can find no reputable evidence that this is a real phenomenon.

On this next slide, we see Ipamorelin, which is a growth hormone releasing peptide that we’re offering in combination with CJC-1295. Since this peptide was previously discussed in the sermorelin presentation, I won’t repeat everything here except to say that together with CJC-1295, they have synergistic effects on growth hormone release. It has a longer half-life of approximately 120 minutes, and only minimal effects on prolactin and cortisol production when dosed up to 100 micrograms.

Speaking of dosing, this can vary, and there’s no standardized dose for everyone. A typical dosing protocol might be 0.05 ml sub-Q at bedtime five nights a week. This can be increased to 0.1 ml sub-Q at bedtime five nights a week if desired. Also, a second morning dose can be added. The longer half-life of the drug combination makes the success of a morning dose influencing a GH spike more likely than would be a morning dose or sermorelin with a shorter half-life. Since we already know that GH could be mitogenic and also that GH deficiency can mask hypothyroidism. An ideal patient would be one with no known cancer or untreated thyroid conditions.

Here’s a photo of the complete package. We offer CJC-1295/Ipamorelin at a concentration of two milligrams/two milligrams per ml in a two-ml vial. This is ready to use, no reconstitution is necessary. It can also be ordered with the injection supplies such as a 30-gauge 5/16-inch with half-ml insulin syringe and alcohol swabs. Please note that refrigeration is required.

Now let’s change topics for our next product PT-141, which is also called Bremelanotide. I’ve included some statistics I found such as 30 million women suffer from female sexual dysfunction. Problems with sexual desire, arousal, orgasm and pain are common in the United States, and between 32% and 58% of women reporting one or more of these problems in the past year. 30 million men, too, suffer from erectile dysfunction. As you might expect, this incidence increases between ages 40 and 70. Because some patients are more reluctant to discuss sexual dysfunction or ED, the true incidence is probably much higher.

We can say that sexual dysfunction is difficulty experienced by an individual during various stages of normal sexual activity. There can be a lack of desire or decreased arousal, pain and discomfort or inability to climax. Now as we age, a tapering off of libido and performance can generally be considered normal. If it’s a burden or causes distress for a patient, then it becomes a problem that you can help treat.

For women, current treatments focus on four areas, which include psychosocial which is therapy and counseling, hormonal which is androgen replacement therapy such as estrogen and testosterone, or vasodilation which might be oral PDE5 inhibitor therapy such as sildenafil or tadalafil, or topical prostaglandin therapy such as alprostadil cream. The last treatment area is the neurobiological, which includes dopamine agonists, flibanserin which has a mixed mechanism of action, and today’s topic the melanocortin agonists including PT-141.

Here I’m including a picture of the chemical structure of PT-141. I’ve also noted that the half-life is approximately 120 minutes. Now today I’m not going to be reviewing the physiological processes of how PT-141 works in the brain, but I am including a few references at the end for additional reading if you’re interested. I will say that PT-141 is a synthetic analog of alpha-melanocyte-stimulating-hormone and as the active metabolite of melanotan II and that it acts on the melanocortin receptors MC3R and MC4R in the hypothalamus. In men, in can induce erections and restore erectile function. In women, in can influence subjective arousal and desire. For men, this is easily measured. For women, the effectiveness was measured by subjective interviews and questionnaires, which revealed an increase in desire after using PT-141. Women reported more satisfaction with their level of arousal compared to women receiving placebo.

It’s interesting that PT-141 is effective in men who don’t respond well to PDE5 inhibitors, such as sildenafil and tadalafil. Treatment failures can be somewhat common with PDE5 inhibitors. For instance, it’s known that these agents especially sildenafil can lose their effectiveness over time. They also requires sexual stimulation to be effective, whereas PT-141 will initiate an erection without the need for sexual stimulation. This might offer a therapeutic advantage over the oral agents by instilling confidence in the ED patient prior to play and activity. Put in other way, the patient can rest assured knowing that it’s going to happen whether he’s interested or not.

Due to their mechanism of action of prolonging nitric oxide release, the PDE5 inhibitors are contraindicated in patients who also take vasodilators such as nitrates. PT-141 does not cause systemic vasodilation and does not have this drug interaction with the nitrates. It’s also known to have a synergistic effect with sildenafil and thus may provide a nice treatment alternative in patients whom higher doses of a single agent are not as effective or well tolerated. Many side effects are dose-related so it follows that if you can get a good result with lower doses, this would decrease the risk of side effects.

Moving on to dosing, we’ve seen that doses vary with no standardized dose for everyone. A typical dosing protocol for women would be 0.5 milligrams to one milligram, which is 0.05 ml to 0.01 ml sub-Q into the abdomen one to four hours before needed. The patient will then adjust the timing of subsequent doses according to the response to this first dose. For men, the dose is usually a little higher to start, one to two milligram, which is 0.1 ml to 0.2 ml sub-Q into the abdomen one to four hours before needed. Men who failed on PDE5 inhibitors might start with higher dosing maybe four milligrams. Again, the timing of administration of subsequent doses will be adjusted according to patient response.

Here’s a photo of the complete package. We offer PT-141 at a concentration of 10 milligrams per ml in a two-ml vial. This product is ready to use, no reconstitution is necessary. It can also be ordered with injection supplies such a 30-gauge 5/16-inch 1/2 ml insulin syringe and alcohol swabs. Please note that refrigeration is required.

Since we just went over dosing, in these next three slides, I wanted to talk a bit about the adverse reactions seen with PT-141. Adverse reactions are primarily dose dependent, with transient nausea reported in patients ranging from 15% at lower doses to 35% at higher doses. Nausea is most likely after the very first dose and subsequent doses have a lower risk. It’s also known that co-administration with ondansetron can help treat and prevent this nausea. Antidotal evidence also suggests that co-administration with ranitidine might help. Other side effects reported include flushing, headache, vomiting, sweating, and increases in blood pressure. Some of these side effects such as vomiting can be delayed by several hours. Again, most of these are dose-related. Most of these side effects were mild to moderate. There’s good news, too. There’s no significant drug-related hypotensive or orthostatic hypotensive effects have been noted. Due to the nature of the drug in situations in which it might be used, I want to point out that there’s no clinically significant drug interactions that have been found between ethanol and PT-141 in either men or women. Because of the potential dose-related side effect of high blood pressure, the ideal patient for this drug would have no untreated hypertension.

The last one we’re going to go over today is BPC-157. Pentadecapeptide BPC-157, composed of 15 amino acids, is a partial sequence of body protection compound or BPC that was discovered in and isolated from human gastric juice. I’m including the amino acid sequence for you. BPC-157 is found to be much more stable than most peptides.

It’s hard to give an exact number for the half-life, but it is thought to be 24 hours or more since there’s no degradation in human gastric juice for 24 hours. Some secondary references and discussions mention a four-hour half-life, but there’s no reliable source for this information. Drug testing references show that it is known to be stable in urine for up to four days.

BPC [inaudible 00:19:18] from animal studies to include accelerated wound healing. By that, I mean it promotes tendon and ligament healing, promotes tendon to bone healing, promotes bone repair. It’s also thought to increase growth hormone receptor expression in tendon fibroblasts. Additional benefits shown from animal studies include improved healing of chemical and thermal burns, and increased blood flow to damaged tissues. We’ll also see improved nerve regeneration and increased collagen synthesis. In search of the available literature will reveal that many additional benefits were claimed as well.

Moving on to dosing, we again see that doses vary with no standardized dose for everyone. Doses range from two micrograms per kilogram per day to as much as 10 micrograms per kilogram per day. A typical dosing protocol might start with 200 micrograms to 300 micrograms, which is 0.1 ml to 0.15 ml sub-Q every day. This dose can be increased and an additional dose can be added if desired. Because BPC-157 increases blood flow to damaged tissues to angiogenesis, an ideal patient will have no known cancer or tumor growth because of the risk of pathological vascularization.

Again, here’s a photo of the complete package. We offer BPC-157 at a concentration of two milligrams per ml in a five-ml vial. This product is ready to use and no reconstitution is necessary. It can also be ordered with injection supplies such as 30-gauge 5/16-inch 1/2 ml insulin syringes and alcohol swabs. Please note that refrigeration is required.

The next four slides are my references and some additional reading. This concludes today’s presentation. Thank you for listening. At this time, I’ll be glad to answer your questions.

Okay, looking at these questions here. Scroll back to the beginning. I see one right away that talks about stuffy nose with PT-141 and a cough. I have read that, too. I’ve read that more of an issue with the nasal sprays, which we don’t currently offer due to a couple of reasons. One is that it’s huge cost. Two, there’s more difficulty adjusting the dosage. They’d actually… When they first started studying at the FDA actually, FDA actually halted the studies because the spikes in blood pressure. The manufacturer blames that on irregular dosing, which is why they then started to promote the injections instead. So yes I have heard of that, but I think that’s more with the nasal spray.

Here’s an easy question. Will they be able to obtain a copy of the slides after the webinar? Sure, they’re going to make it available on our YouTube page at the very least.

Looking here. Are we licensed in California? Yes, we are licensed in California. California is a bit different and that they recently changed their sterility testing requirements along with stability and degradation study requirements. So we are licensed and a lot of our products already meet their requirements. Some of them didn’t, so we had to do some additional testing to get them all up to speed. Yes we are licensed, and yes everything will be available in California.

We actually have offered oral BPC. The question is what about oral BPC? We do offer… We have offered that. Today’s topic was about the injectable, but yes we do also offer the oral BPC as well.

Here’s one I’m going to take. How does this compare clinically speaking to sermorelin? That’s a good question. If you read all the stuff about what’s more popular worldwide, it’s the CJC-1295, either with or without the DAC. I understand the rationale for sermorelin, but it’s got limitations that I touched on with the short half-life. You have to try to synchronize the administration of these medicines to when there’s going to be a GH pulse. The biggest GH pulse occurs in those early morning hours after sleep. If you use the drug like sermorelin, which has a pretty short half-life, it’s just more difficult to get that where it’s still having an effect when the GH pulse is being released. With the CJC-1295 with its longer half-life, you’re more likely to have success synchronizing the administration of your medicine to when you’re going to have that GH pulse. So sermorelin does have an effect, but CJC is probably better.

Are there any human studies on BPC-157? That’s another excellent question, and I looked very hard for that. The only thing I found was that they had started some phase-one studies based at a hospital in Mexico that were halted and withdrawn. I don’t know anything about it. I’m sure more are going to be forthcoming, but the only one that I had hoped for was actually withdrawn.

Let’s see. Have you gotten feedback on dosing levels and length of treatment for the CJC-1295 and Ipamorelin? I found that I had increased my dose to 0.253 in order to see results. Yes, the dosages I listed are starting point, your common doses and it’s the beginning. You want to of course titrate to effect as it where and some people will require more. I think the BMI is an influence on that, and I think estrogen level is another influence on that. So yes, those levels are carved in stone, and we do actually see them where they are increased. Normally, it’s just like one vial to last a month. We definitely see some people that take at least double that, so yes. Yes, so you might have to increase the dose depending on the patient.

What would be the indication for BPC-157, wound healing, numbness associated with sexual dysfunction? I think it’s more for recovery from injuries, probably the people that work out a lot or exercise enthusiasts. I think amongst others, it will help them recover to get them back into the gym more quickly. Numbness associated with sexual dysfunction? I don’t see where it’s going to hurt. I mean if you really read up on BPC-157, they almost want to take you with a grand assault because they think it’s beneficial for almost everything. So I don’t think it’s going to hurt. I don’t see a direct connection with that, but it couldn’t hurt. Again, the indications wound healing, yes for a patient who’s been injured, but I see it more for people that are trying to recover from the gym so they can go back to the gym.

When using BPC-157 for injury recovery, should this be injected close to the injection site of injury or this is not necessary? It depends on who you’re reading. If you’re reading somewhat I call secondary references and discussion blogs, they say you should inject to the site of injury. If you read more formal stuff, they just say just give it sub-Q. It’s a systemic-acting drug and it should have an effect across the whole body. So my takeaway on that is if you want to inject to the site of injury, you can. It’s not going to hurt anything, but no I do not think it’s necessary.

Are these medications FDA approved? I touched tangentially on the sermorelin, which was at one time, but it was just withdrawn from the market. No, these are not FDA approved. As a compounding pharmacy, a lot of our stuff is not FDA approved. These are all going to be prescribed off label. There are studies and most of them anyway they show their safety. The BPC-157 is predominantly animal study, but I wish I had a better answer. No, they’re not FDA approved.

Let’s see. When is the best time for use of the CJC combo in any relationship with the diet, and do you cycle? If I didn’t say it, I apologize. I thought what I meant to say at bedtime that’s the best time to use it. You want to be with diet. You wanted to be on an empty-stomach diet, at least an hour or two hours after eating. The purpose of the medicine is to encourage your body to release its own natural source of growth hormone. Your body doesn’t want to do that if you’ve recently with a high blood sugar. I think high-fatty acid level, too. So that’s why your diet has to be empty stomach, otherwise the medicine just won’t really do anything for you. If you talk about cycling, usually… I thought I said too, usually just five days a week. So you’re taking off at least two nights a week as a partial cycle. We also do see some people that do two months on and one month off. Yes, it’s probably not a bad idea.

Already answered that one. CJC-1295 and Ipamorelin with a patient who have higher BMI, an example higher than 27, need higher dosing? Yes, probably, yes. It’s going to be the prescriber’s decision, but yes they probably would go for that. They have found that people, as I’ve mentioned earlier, with a higher BMI, and I think women with higher estrogen they might need higher dose.

How many of these are licensed under the FDA with only animal studies? The one that’s predominantly animal studies is the BPC-157. Like I said, there was one study I read about humans, but for whatever reason it was retracted and withdrawn. The others they all have human studies. I will say just being honest if you read up on the PT-141 Bremelanotide, it seems most of the studies are drawn out of University of Zagreb in Croatia and with a few other studies in China. I would like to see… Did I say CJC? I’m at BPC-157. For BPC-157, I’d like to see a broader spectrum of researchers reviewing the products. They seemed to be focused on those two groups. Again, that’s on BPC-157. Just there seems to be a limited number of researchers. With the CJC-1295 and the PT-141, yes there are several human studies. I’m pretty sure I’ve listed some… I know I’ve listed some references at the end of this that you can check out later.

Are you licensed in Alabama? Unfortunately, we are not currently licensed down in Alabama.

Some of these are repeat. Can we ship all over the country? Well, at the moment since we’re not licensed in Alabama, we cannot ship to Alabama. We can ship everywhere else. We have an affiliation with the pharmacy in Texas, so we can even ship there. Yes, we are licensed in Oklahoma.

What consideration would you take regarding managing IGF-1 and would you cycle peptide therapy now? You probably would want to measure your IGF-1 levels, of course. There’s such a wide variation on a normal level depending on the test and who’s doing it. So probably the best way to manage the IGF-1 is to get a baseline reading before you start this CJC or the 1295 therapy. Then you’re going to revisit it to see if you moved the needle or if you changed it. So that’s far the best way to manage and get a baseline reading and then see if it changes.

Does PT-141 cause freckles to become darker? I did read that some people think that’s possible because it was derived from that alpha-melanocyte-stimulating-hormone, which actually was initially developed as a sunless tanning agent, so. I haven’t read what’s obviously the case that it will definitely promises to happen. Yes, in theory, I can see where it might.

What is the business model that doctors use with these peptides? Is the script sent in and then the medicine is sent to the patient? Yes, pretty much. I mean, we’re predominantly a 503A licensed pharmacy so we get the order, however, electronically, in the mail, fax, what have you. Then yes, we would send it directly to the patient. If I’m reading between the lines, if you’re asking if it can ever go to the doctor’s office, we do frown on that. Inspector is frown on that, but there’s an exception. If it’s the first time an injectable medicine is being prescribed, I think we are allowed to send it to doctor’s office, so they can aid the patient on how to use it that very first time. Then all subsequent refills would have to go to the patient’s residence.

Where can I get information about your quality controls to decide amongst your competitors? I’m sure if you… I would have to follow up with you on this. We do have very good quality controls. We take it very seriously. We’ve got a big department, that’s all they do. I don’t have the answers for you on that. If you reach out to us, I think the address is info@wellsrx.com, we will get back to you on that. You also ask about the price list. I’m sure we can get that for you, too. Again, that was info@wellsrx.com.

Is CJC-1295 available not reconstituted? Not at the moment. I’m sure if there’s enough of a demand for it, we could do that. I mean, it wouldn’t hard to do it all. I know that you have an increased maybe a little better shelf life with it. I guess you’re asking could have been sent lyophilized. In theory, you could. I know a lot of patients they, especially with… this is related to the sermorelin. My number of patients and usually patients who also got ACG, which uses a different diluent. They mix the diluent and they ruin the product and they get frustrated, and then it has to be replaced. So we’re trying to… We mix it ahead of time. We’re trying to avoid that issue, and it’s a very, very common issue. Weekly is not daily where patients have mixed it incorrectly either with the wrong diluent or the wrong instructions on mixing it. So we’re just trying to help them out and send it pre-mixed, but we could send it lyophilized. Unfortunately, I don’t know our plans for that but if enough people are interested, I’m sure we could do it.

Could you advise me on when to use oral versus injectable? I asked because many of my patients just will not do at-home injectables. Yeah, I get it. I understand, I mean, nobody wants to poke themselves with a needle on a regular basis, but it’s a lot more effective that way. I guess maybe one exception might be the BPC-157 oral. In general, well, let’s take them one at a time. With the CJC-1295 and Ipamorelin, I think you pretty much have to inject it. It’s going to be degraded. There’s that theory that you could do it as a sublingual where it’s absorbed through the skin, under the tongue and gets into the bloodstream. In theory, that not what happens. So I’ve a mixes with it form of slurry and you swallow it. It becomes an oral dose and it’s also… It’s got a pretty good size molecular weight so it’s not really going to absorb orally. If you swallow it, your stomach is going to destroy it right away. So at least for the CJC-1295, pretty much it has to be injectable I’d say.

For the PT-141 Bremelanotide, cost is going to be a big consideration. If they’re concerned about the needles, you might consider the nasal. Even then, I’m a little skittish with that because I know it’s going to cost a ton. I also know that it’s much more difficult to regulate your dose to avoid side effects pf high blood pressure. So as far as the PT-141, I don’t know about oral, but there is maybe going to be nasal but even then, I’d still say the injections on that, too. Sorry, I wish I had a better answer.

Is there any contraindication with doing GHRPs, CJCs, et cetera and testosterone pellets? No, you can them at the same time. I’ve actually read that they can actually compliment each other as far as muscle strength and muscle growth. So yeah, you can do them together; sorry.

How do you feel about oral versus injection BPC across names like irritable bowel, sports injury, concussion. I’m going to say this one is hard to answer because I wish they had more oral studies to say which is more effective in people. The drug is pretty safe. It’s also pretty stable, so. I’m sure you can take it orally, but I just like the injectable better. I think you avoid… Even though it’s stable in the gastric juice, there’s still might be some first pass metabolism what have you. You need to skip all that if you inject it, so. I still think the injectable is better.

Just like with the stem cell craze, are the claims in advertising of these products closely monitored for fraud like fraudulent claims? I’m going to maybe paraphrase this question. Do I think this stuff is for real or do I think it’s kind of fraudulent? I’ll take it like that. No, let’s take them one at a time. The CJC-1295 with Ipamorelin, there’s real science behind that. There’s real science behind the starting chemical, the sermorelin, which was actually was on the market. They really is a snippet of the GHRH, and it really does have an effect on promoting the release subsequently of growth hormone. It’s not a fraud.

PT-141 is not a fraud. It really does it. When they started testing it, it had some side effects that’s scared the FDA, but that was as I said earlier was the intranasal dose. It really does cause reactions. I think the biggest concern, to improve libido in women. These are facts. I mean, they have studies. I would be mostly concerned with that one about another fraudulent claim, but what about the side effects? I think you need to be hypervigilant to manage the side effects, getting some ondansetron or ranitidine on board from the get-go to make it more pleasant for the patient. I don’t think a nausea or vomiting six to 14 hours later is pleasant, so I think you need to manage that. It’s not fraudulent. It really does what it says it’s going to do.

BPC-157, I did mention this earlier. I think I confused it a bit with CJC. There’s a lot of claims. There’s tons of stuff. It’s almost like a miracle drug, but again the researchers are all based at a one university in Croatia and a couple of researchers in China. I’d like to see a broader spectrum of people looking, studying the benefits of that drug, so. I don’t think it’s a fraud. It almost sounds a bit too magical to me, but it’s not fraudulent.

Gee, how does this compare to GHRP-2? GHRP-2 is stronger. I think it has more of a possible aggravation of cortisol and prolactin levels. It’s a little weaker, but the side effects are better. Specifically, I’m talking about the Ipamorelin in relation to the GHRP-2. GHRP-2 is stronger with side effects.

How frequently can PT-141 be given? Could it be given on a daily basis? I don’t know how healthy and safe it is to have a strong erection like that every single day. I guess as long as you’re avoiding the potential of priapism, which is like a four-hour or longer duration erection, that’s the main concern because that could to lead to tissue, vascular damage. I haven’t read anything that says that you can’t use it every day. I’m just not really familiar with somebody using something like that every single day. As long as they’re not getting a four-hour erection, I can’t really think of a reason to tell them no.

Do heavy carbohydrates or alcohol around injection time blunt the effects of CJC Ipamorelin. Yes, probably. As I had mentioned, the drug works best w an empty stomach because it’s trying to indirectly encourage the release of growth hormone and your body doesn’t want to do that if you’ve got a high blood sugar or a lot of fatty acids in the blood, so. No, no carbohydrates and the alcohol, too and all those calories, so no. I mean, if you want to do all those things in the same day, you can, but I think there needs to be a two-hour separation.

What is the pricing of these formulas? I’m sure somebody will get back to you on that.

What is the duration of action PT-141? That’s kind of vary for every person and that’s also going to vary on how much you’re injecting. I kind of alluded to it when I say they’re going to do one dose then they go like one to fours before and see how they respond to that dose. I think it’s good to do that, I don’t have a solid. It’s rather than to say I know it’s kind of vary and it’s probably going to be dose-related.

Would you see BPC-157 useful in patients after joint replacement surgery? Yes, and in theory anyway. I mean, that’s kind of what it’s for. I mean, it’s basically just “to heal”. It seems to be hat it does and so it definitely could not hurt, and yes it probably would help.

Let’s see. Would BPC-157 help postop on healing? Yes. I mean, at least there’s studies that say it does.

Is there a drug holiday period recommended after a CJC cycle, for example CJC for 10 weeks and one month off before resuming? I’ve heard of like five-day out of seven and I’ve heard like two months on, one month off. So I guess it is kind of… I guess 10 weeks and I said two months, I guess that is yes, so two months on, one month off. I can see where there might not be a bad idea.

Yes, we are licensed in Washington State. Yes, we are licensed in Hawaii.

In regards to the prolactin and cortisol, do you know how significant the rises in those levels would be if you’re going greater than 100 micrograms? It’s a good question, and I kind of notice is the fact that the way it’s often prescribed, they are going higher than 100 micrograms, so. I want to say it’s probably minor. If it was really significant, then they would probably back off on the dosing. They see routinely get-go above that, so I would infer from that that the significance is minor, otherwise they wouldn’t be dosing that high.

Prices again. Somebody can definitely get back to you on that if you go to info, email info@wellsrx.com. We can get back to you on that. Covered by insurance? Unfortunately, probably not. I can’t think of hardly any compounded products prepared by a compounding pharmacy that are covered by insurance. Honestly, they seem to look for all sorts of reason to not cover stuff and they don’t cover this either.

I think I mentioned this. Is there any contraindications with the GHRP in CJC and testosterone? No. I have noted that they are… There are studies that show they can’t be beneficial in combination.

Do you see any benefits from these peptides even if there is no increase in IGF-1? Yes, it could be possible because it is possible to have a low growth hormone level and what looks like a normal IGF-1, too. The only way to I think to make sure is I guess if you think you have normal IGF-1 but you’re still concerned if your GH is low, I think you want to do that arginine-GHRH challenge test to see if the GH is low. You might see it really is low even though you have a normal-looking IGF-1. So yes, it is possible. There would still be some benefit from this with a normal-looking IGF-1.

I think I answered that one. Can we compound skin care and cream, lotions? Yes, we do. We do not currently offer tesamorelin. Sorry about that.

Do CJC-1295 and Ipamorelin work in people older than 70 years old? Yes, I don’t see any problem with that at all. It might offer them some benefit.

I have a correction. I’m told that we’re not currently offering the oral BPC, but it will be back soon.

Let’s see. Scrolling here. I think I’ll see… Are you licensed in Louisiana? Yes, we are. Yes, we’re licensed in New York. All right, that’s all I see. Will it be a benefit to a patient whose IGF-1 is already in the higher upper range? Yes, it might be because as I say… I mentioned just a minute ago just because you have a normal-looking IGF-1, you can still have a low GH. So yes, it might be beneficial.

Are there contraindications with other meds such as hypertension? Well, the PT-141 Bremelanotide if dosed too high can aggravate high blood pressure, so there could be a drug disease contraindication, but I did mention that. Since also going a little further with this, since hypertension medicines tend to cause lowering of blood pressure, the PT-141 doesn’t do that. If anything, it might aggravate it and make it go higher. So no, there’s not going to be a contraindication with the PT-141 as far as lowering blood pressure along with that hypertension medicine. So no, that would be fine. There would be a drug disease contraindication for untreated high blood pressure.

I don’t see anymore. All right, well, that’s it for the questions. Again, my name is Ken Pettengill. I hope this was of some benefit to you. You can reach out to us again @infowellsrx.com. I’ll be glad to follow up with anything that you have in more detail if you’d like.

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