New Antidepressant Improved Sexual Function in Depressed Men and Women

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Nelson Vergel

Founder, ExcelMale.com
It finally got approved (Sept 2023) after years of rejections from the FDA.


"Studied in over 5,000 patients, Travivo (Gepirone) has been found to have a favorable safety profile and be well-tolerated. The drug's unique single mechanism of targeted 5HT1a agonism, allows for the relief of depressive symptoms without significant side effects. The most frequent adverse events seen in clinical trials were lightheadedness and nausea, which generally were mild, of short duration, and related to dose escalations. Adverse event data from all trials, as well as sexual functioning data collected using standardized scales in numerous Travivo trials, indicate that Travivo does not cause sexual dysfunction in depressed patients, a common side effect among most available anti-depression therapies."
Source


From Wikipedia:

"Gepirone is an antidepressant and anxiolytic drug of the azapirone group that was synthesized by Bristol-Myers Squibb in 1986 and has been under development for the treatment of depression but has yet to be marketed. It has been under development in the U.S. in an extended release form (referred to as gepirone ER), but despite completing phase III clinical trials and demonstrating efficacy, it has been rejected multiple times by the Food and Drug Administration (FDA) during the drug approval process. However, in March 2016, the FDA reversed course and ruled favorably on the efficacy of gepirone, clearing the way for its eventual approval. As of January 2018, the drug is still in pre-registration. In addition to its antidepressant and anxiolytic properties, gepirone has been found to improve symptoms of sexual dysfunction in men and women. Moreover, the pro-sexual effects appear to be independent of its antidepressant and anxiolytic effects."



The Effect of Gepirone‐ER in the Treatment of Sexual Dysfunction in Depressed Men


Introduction
Sexual dysfunction is common in patients with major depressive disorder (MDD). Antidepressant medications especially the selective serotonin reuptake inhibitors (SSRIs) may improve depressive symptoms but further decrease sexual function. Gepirone extended release (gepirone‐ER) differs from the SSRIs in only affecting the 5‐HT1A receptor and has demonstrated efficacy in treatment of depression and sexual dysfunction in depressed women. This report describes the effect of gepirone‐ER on sexual function in depressed men.

Aim
The aims of this article were to study the effects of gepirone‐ER on sexual function in men with MDD and to determine if positive effects are independent of antidepressant or anxiolytic activity.

Main Outcome Measures
The main outcome measures of this article were Hamilton depression rating scale (HAMD‐17), and changes in sexual functioning questionnaire (CSFQ).

Methods
In an 8‐week study, gepirone‐ER, placebo, or fluoxetine were administered in a double‐blind fashion to 181 depressed men. The CSFQ results were used to determine quality of sexual function. To test for an antidepressant or anxiolytic effect, a 50% reduction in HAMD‐17 score separated antidepressant responders from nonresponders, and item 12 of the HAMD scale (psychic anxiety) scores of 0 or 1 separated anxiolytic responders from nonresponders.

Results
Gepirone‐ER treatment improved total sexual function compared with placebo measured by the CSFQ at weeks 4 (P = 0.012) and 8 (P = 0.046). At 4 weeks, almost every CSFQ domain is improved. The orgasm domain was especially improved, 67% by week 4. Gepirone‐ER antidepressant and anxiolytic nonresponders showed significant improvement in sexual function. Fluoxetine treatment did not produce improvement. In fact, fluoxetine‐treated subjects had lower scores on the total CSFQ, less than placebo, and significantly less than gepirone‐ER.

Conclusion
Gepirone‐ER improves sexual dysfunction in depressed men. All domains of sexual function improved. Gepirone‐ER has a pro‐sexual effect independent of antidepressant or anxiolytic activity.

Reference: Fabre LF, Clayton AH, Smith LC, Goldstein I, and Derogatis LR. The effect of gepirone‐ER in the treatment of sexual dysfunction in depressed men. J Sex Med 2012;9:821–829.


Gepirone-ER Treatment of Hypoactive Sexual Desire Disorder (HSDD) Associated with Depression in Women

There is currently no Food and Drug Administration (FDA)-approved treatment for hypoactive sexual desire disorder (HSDD). FDA approval of products utilizing testosterone has been delayed due to possible safety concerns. Flibanserin, a 5-HT(1A) agonist, 5-HT(2) antagonist, and gepirone-ER, a 5-HT(1A) agonist, have been shown to have activity in treatment of HSDD. However, more recently, the FDA issued a non-approval letter for flibanserin. To study the effect of gepirone-ER on HSDD in women with major depressive disorder (MDD). At baseline and post-treatment visits, a trained psychiatrist made diagnoses of HSDD based on Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria. Subjects meeting criteria for HSDD were followed to observe the effect of gepirone-ER (20-80 mg/day), comparator antidepressants (fluoxetine, 20-40 mg/day or paroxetine, 10-40 mg/day), or placebo in reversing DSM-IV diagnosis. A subpopulation of women with Hamilton Depression Rating Scale (HAMD-17) entry scores of 18 or less was evaluated. Adverse events (AEs) of sexual dysfunction were also collected. Number (%) of patients who no longer met criteria for HSDD (percent resolved). Eight hundred seventy-five women (18-64 years of age, average 38 years old, ∼80% premenopausal) entered three studies; 668 (72.5%) completed. Only 161 (18.4%) met DSM-IV criteria for HSDD. Cumulatively, 63% of gepirone-ER-treated patients reversed their diagnosis of HSDD compared to 40% of placebo-treated patients at end point (8 weeks) (P = 0.007). Selective serotonin reuptake inhibitor-treated patients were not different from placebo. Significant results for gepirone-ER occurred by week 2 (P = 0.0001). Patients who were mildly depressed (HAMD scores of 18 or less) also improved at week 2 (P = 0.01) and week 8 (P = 0.07). Sexual dysfunction AEs were significantly less in gepirone-ER-treated patients than placebo (P = 0.013). Gepirone-ER may have efficacy in the treatment of HSDD among depressed and possibly nondepressed women. Efficacy occurs by week 2, and does not seem to be purely an antidepressant effect.

Reference: The journal of sexual medicine, 05/2011, Volume 8, Issue 5

****************


After a few tries, it got approved this week

Update Sept 28 2023: FDA Relents, Approves Novel Antidepressant After Many Rejections
 
Last edited:
Defy Medical TRT clinic doctor
Has someone here on this forum tried Travivo (Gepirone) if so could you share your opinion about this medication

Glad this thread popped up. I researched that this medicine is not fda approved in the US. I asked a psychiatrist to prescribe something like it, and got Buspar. So far the reviews I’ve read are positive. Haven’t tried it yet.
 
Glad this thread popped up. I researched that this medicine is not fda approved in the US. I asked a psychiatrist to prescribe something like it, and got Buspar. So far the reviews I’ve read are positive. Haven’t tried it yet.

Buspar is an anxiolytics, not an anti depressant. It is not the same thing and will not necessarily help. Your psychiatrist is treating you for anxiety and is assuming it will help with sex. It may, if the problem is from anxiety. If it is anxiety, then buspar is a good choice.
 
Buspar is an anxiolytics, not an anti depressant. It is not the same thing and will not necessarily help. Your psychiatrist is treating you for anxiety and is assuming it will help with sex. It may, if the problem is from anxiety. If it is anxiety, then buspar is a good choice.

I’ll see if it helps. I didn’t tell the psych about anything sex related. I refuse to bring it up anymore, too embarrassing.
 
I’ll see if it helps. I didn’t tell the psych about anything sex related. I refuse to bring it up anymore, too embarrassing.

You shouldn’t be embarrassed. About 20 years ago, I asked my physician about viagra. We had a great conversation. He was about my age and was using it himself. Believe me, doctor’s, psychiatrists, and therapists hear it all over the years. They won’t judge you, you are not that unique. Sex is a physical and psychological event, and dysfunction is an interesting medical puzzle for a good doctor, one they want to help you solve. You can give up, and deny yourself one of life’s most meaningful experiences, or tackle it head on. I’m glad I did. A lot of guys my age give up on staying fit, looking good and even sex. They embrace their expanding stomachs, saggy muscles, and brag about how much they used to bench in the 1970s, a number that goes up every time they tell the story. Some even joke about the lack of sex, and as a result of this mentality, their wives are also in the same boat. You can be that guy, but you don’t have to be. Your choice. Trust me guy, this is a critical decision. I’m 65 and have the best sex of my life with my wife 3-4 times per week. I’m on 140 mg of test a week and take daily low dose Cialis and throw in 50 mg Viagra for sex. I get these from Allday Chemist. Don’t do this to yourself. This is probably an easy fix.
 
You shouldn’t be embarrassed. About 20 years ago, I asked my physician about viagra. We had a great conversation. He was about my age and was using it himself. Believe me, doctor’s, psychiatrists, and therapists hear it all over the years. They won’t judge you, you are not that unique. Sex is a physical and psychological event, and dysfunction is an interesting medical puzzle for a good doctor, one they want to help you solve. You can give up, and deny yourself one of life’s most meaningful experiences, or tackle it head on. I’m glad I did. A lot of guys my age give up on staying fit, looking good and even sex. They embrace their expanding stomachs, saggy muscles, and brag about how much they used to bench in the 1970s, a number that goes up every time they tell the story. Some even joke about the lack of sex, and as a result of this mentality, their wives are also in the same boat. You can be that guy, but you don’t have to be. Your choice. Trust me guy, this is a critical decision. I’m 65 and have the best sex of my life with my wife 3-4 times per week. I’m on 140 mg of test a week and take daily low dose Cialis and throw in 50 mg Viagra for sex. I get these from Allday Chemist. Don’t do this to yourself. This is probably an easy fix.

I appreciate your response, but I have told about 5 GP’s, 4 endocrinologists, 2 psychiatrists, 1 neurologist, 1 sleep doctor.

Because I’m young, and high shbg, high testosterone, the only medicines I received, were antidepressants and Xanax.

I couldn’t work for over 3 years because my brain fog was so bad. Now I can’t handle working because my whole 20s was a disaster, I’m exhausted, and I don’t get any treatment if I try. I managed to get Natesto and this Buspar in the last week, so I’m hoping that works.
 
You shouldn’t be embarrassed. About 20 years ago, I asked my physician about viagra. We had a great conversation. He was about my age and was using it himself. Believe me, doctor’s, psychiatrists, and therapists hear it all over the years. They won’t judge you, you are not that unique. Sex is a physical and psychological event, and dysfunction is an interesting medical puzzle for a good doctor, one they want to help you solve. You can give up, and deny yourself one of life’s most meaningful experiences, or tackle it head on. I’m glad I did. A lot of guys my age give up on staying fit, looking good and even sex. They embrace their expanding stomachs, saggy muscles, and brag about how much they used to bench in the 1970s, a number that goes up every time they tell the story. Some even joke about the lack of sex, and as a result of this mentality, their wives are also in the same boat. You can be that guy, but you don’t have to be. Your choice. Trust me guy, this is a critical decision. I’m 65 and have the best sex of my life with my wife 3-4 times per week. I’m on 140 mg of test a week and take daily low dose Cialis and throw in 50 mg Viagra for sex. I get these from Allday Chemist. Don’t do this to yourself. This is probably an easy fix.

I'm 23 years into and no solution found yet.
 
I wonder what happened to this drug.

It appears they have changed the name. There were some press releases regarding having a 3rd party doing the marketing as well:


Fabre-Kramer Submits NDA Amendment for EXXUA™ for Treatment of Major Depressive Disorder​

HOUSTON, Jan. 04, 2023 (View press release on CisionNewswire.com)

New Class of Antidepressant’s Novel Mechanism Uniquely and Directly Addresses Important Unmet Needs

HOUSTON, Jan. 4, 2023 /PRNewswire/ — Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) today announced that on December 23, 2022, it filed an NDA Amendment with the Food and Drug Administration (FDA) for its novel mechanism antidepressant EXXUA™ (gepirone ER) for treatment of Major Depressive Disorder (MDD).
 
Thanks @BadassBlues !

Wow, in my home town!

"Studied in over 5,000 patients, EXXUA's unique mechanism of targeted single serotonin (5HT) 1a receptor agonism relieves depressive symptoms without significant side effects. EXXUA does not cause sexual dysfunction in depressed patients, a common side effect among most available antidepressants. In late 2021 FDA imposed safety labeling warning of serious risk of sexual dysfunction on all SSRI and SNRI products. EXXUA was shown superior in sexual functioning to SSRIs in several studies and to not cause any meaningful weight gain."
 
Common adverse events (≥5%) that occurred in at least twice as many gepirone versus placebo patients included dizziness (49% vs 10%, respectively), nausea (35% vs 13%), insomnia (15% vs 5%), abdominal pain (7% vs 3%), and dyspepsia (6% vs 2%).

This list of side effects associated with 5HT1A agonism is the same list you'll see associated with buspirone, which reminds me that 5HT1A agonism has been done already with that drug and others on the market. I don't think there's anything too novel here.
 
I once overdosed on 30mg buspirone (got the dose wrong) - electric shocks in the head (serotonin syndrome), dizziness, nausea, weakness, sweating, and vomited. It did make orgasm very easy to reach, which was the goal but the side effects were horrific. Lower doses 5mg and 10mg did not work.
 
Beyond Testosterone Book by Nelson Vergel
This list of side effects associated with 5HT1A agonism is the same list you'll see associated with buspirone, which reminds me that 5HT1A agonism has been done already with that drug and others on the market. I don't think there's anything too novel here.
Perhaps not novel in the respect that it targets an already well established mechanism of action, but the possibility of a similar drug being refined and even enhanced is a positive.

I have tried Buspirone, it just makes me somewhat docile for lack of a better term. Similar to what Oxytocin does. But that is just my personal experience.

Again, as always… different chemistry between us all.
 
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