Bremelanotide (Vyleesi) for Female Sexual Disorder

[Nelson Vergel]

Rekynda (bremelanotide), an investigational product, is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.

The two Phase 3 studies for HSDD in pre-menopausal women consisted of double-blind placebo-controlled, randomized parallel group studies comparing a subcutaneous dose of 1.75 mg Rekynda delivered via an auto-injector pen to placebo. Each trial consisted of more than 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo with a 24 week evaluation period. In both clinical trials, Rekynda met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments.

http://finance.yahoo.com/news/amag-pharmaceuticals-palatin-technologies-enter-130000216.html

 

[Dr Justin Saya MD]

May offer some promise as an adjunct for post-menopausal women (wouldn't offer some of the health benefits of appropriately administered BHRT) or as standalone treatment for premenopausal females with HSDD not needing BHRT. They are developing it as an "as needed" libido/arousal/function booster similar to "as needed" viagra.

This compound is the same as the peptide PT-141 (still available through some of the research peptide sites) and was isolated from melanotan (another research peptide).

BTW, the stock is $0.50 if anyone is a gambler...but do NOT take stock advice from me!

 

[Nelson Vergel]

Palatin Technologies announced that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, has submitted a New Drug Application (NDA) to the FDA for Rekynda (bremelanotide) for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women. Palatin expects that within 60 days the FDA will determine whether the NDA is complete for filing.

Palatin previously announced positive results for two Phase III trials of bremelanotide for the treatment of HSDD in premenopausal women that met the pre-specified co-primary efficacy endpoints. The Phase III RECONNECT studies for HSDD in premenopausal women consisted of two double-blind placebo-controlled, randomized parallel group studies comparing the as desired use of 1.75 mg of bremelanotide versus placebo, in each case, delivered via a subcutaneous auto-injector. Each trial consisted of more than 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo with a 24 week evaluation period. In both clinical trials, bremelanotide met the pre-specified co-primary efficacy endpoints of median improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments. Women in the trials had the option, after completion of the trial, to continue in an open-label safety extension study for an additional 52 weeks. Nearly 80% of patients who completed the randomized portion of the study elected to remain in the open-label portion of the study. In the Phase III clinical trials, the most frequent adverse events were nausea, flushing, and headache, which were generally mild-to-moderate in intensity and were transient. Source


More details on the drug

 

[Nelson Vergel]

Bremelanotide, an investigational product candidate, is being developed for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The PDUFA date for bremelanotide is June 23, 2019. Bremelanotide is designed to be used in anticipation of a sexual encounter, and is thought to possess a novel mechanism of action that impacts the excitatory neural pathways in the brain to restore sexual desire.

Bremelanotide has been studied in more than 30 clinical trials with over 2,500 women. AMAG’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) was supported by clinical data from two identical large double-blind placebo-controlled Phase 3 studies in which bremelanotide met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured by validated patient-reported outcomes. Women in the trials had the option, after completion of the trial, to continue in an open-label safety extension study for an additional 12 months. Nearly 80% of patients elected to remain in the open-label portion of the study, and all of these patients received bremelanotide.

The most common adverse events were nausea, flushing, injection site reactions and headache. The majority of events were reported to be transient and mild-to-moderate in intensity.

AMAG PHARMACEUTICALS PRESENTS NEW DATA AT THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS ANNUAL MEETING – AMAG Pharmaceuticals

 

[Nelson Vergel]

They changed the name of the drug right before approval

New Sex Drug for Women to Improve Low Libido Is Approved by the F.D.A.

 

[Nelson Vergel]

Treatments that may increase sex drive in women

 

[Nelson Vergel]

A man's story:

"As soon as the bremelanotide (a.k.a. PT-141) arrived in the mail, I shook the white crystal onto a mirror and began to chop it into powder. I snorted some and a bitter taste began its steady descent down the back of my throat. But I wasn’t about to complain. Thanks to a website called Tanresearch.com and $65, I finally had my hands on the most revolutionary sex drug ever created. This potion had undergone studies for almost a decade in a quest to make it the first-ever FDA-approved aphrodisiac to hit the U.S. market." Continue

 

[Cataceous]

...
BTW, the stock is $0.50 if anyone is a gambler...but do NOT take stock advice from me!

Not a bad tip, as it's currently $1.34. But it was a roller coaster, going down to about $0.30 a couple times first, and hitting a high of $1.74 last month.

 

[Nelson Vergel]

HOW SUPPLIED / STORAGE AND HANDLING

VYLEESI (bremelanotide) is supplied as: 1.75 mg bremelanotide in 0.3 mL solution in a single-dose, disposable prefilled autoinjector (NDC 64011-701 01) provided in a carton of 4 autoinjectors (NDC 64011-701-04).

Storage

Store at or below 25°C (77°F). Do not freeze. Protect from light.

SIDE EFFECTS:

Product insert attached (for registered users only)

 

[Will Brink]

A man's story:

"As soon as the bremelanotide (a.k.a. PT-141) arrived in the mail, I shook the white crystal onto a mirror and began to chop it into powder. I snorted some and a bitter taste began its steady descent down the back of my throat. But I wasn’t about to complain. Thanks to a website called Tanresearch.com and $65, I finally had my hands on the most revolutionary sex drug ever created. This potion had undergone studies for almost a decade in a quest to make it the first-ever FDA-approved aphrodisiac to hit the U.S. market." Continue

You try it yet? Desire is not one of my problems, that's for sure. Sounds like an interesting experience though it it works. When I hear lack of desire, hormones are the first place I'd look before jumping on this one (no pun intended) and for some, it's not lack of general desire per se, it's lack of desire the person they have been with for a long time and desire for that person has dropped off. All those guys who don't have any interest in their wives, drop a 20 something pretty girl in front of him and I suspect they desire aspect for physical contact will magically appear. Not the PC thing to say, but it's true. Similar for women too I'm sure. but also a different dynamic I suspect.

 

[Nelson Vergel]

I agree. Desire increases dramatically with "fresh meat"

Having said that, I admire men and women who can have sex with the same person for many years.

 

[Guided_by_Voices]

In my experience and from what I've read, the "desire" aspect induced by this drug is distinctly different for men and women. In men, it is more a case of rapid erections as opposed to desire for sex in the first place. As has been discussed in other threads, having DHT at a fairly high level seems to help create the feeling in men that this drug creates in women. All that said, nothing replaces desire for a specific person. No drug comes close to that.

 

[Will Brink]

In my experience and from what I've read, the "desire" aspect induced by this drug is distinctly different for men and women. In men, it is more a case of rapid erections as opposed to desire for sex in the first place. As has been discussed in other threads, having DHT at a fairly high level seems to help create the feeling in men that this drug creates in women. All that said, nothing replaces desire for a specific person. No drug comes close to that.

Interesting! I'll have to look onto it some more.

 

[Will Brink]

I agree. Desire increases dramatically with "fresh meat"

Having said that, I admire men and women who can have sex with the same person for many years.

Agreed, very admirable and if such drugs help there, great.

 

[Guided_by_Voices]

The melanocortin system seems to be very underappreciated. The study below (yes, just one) suggests Melanotan 2 (the drug from which PT-141 was derived) can have an anti-inflammatory and pro-arterial health affect, so it would be interesting to know if PT-141 has the same benefit.

Pharmacological activation of the melanocortin system limits plaque inflammation and ameliorates vascular dysfunction in atherosclerotic mice. - PubMed - NCBI