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
"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:
