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When the FDA Advisory Committee for Reproductive Health Drugs convened in mid-June to consider approving the nonhormonal agent flibanserin for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, there was no FDA-approved drug for the disorder.
There still isn’t.
After examining data from two US-based Phase-3 trials (and a third trial conducted in Europe), the committee 1) decided that evidence of flibanserin’s efficacy is lacking, and 2) found the prevalence of side effects worrisome. It did agree with drug maker Boehringer Ingelheim that there is “widespread unmet need” for a medical therapy for HSDD.
The two primary US efficacy studies of flibanserin failed to achieve significance for the prespecified co-primary endpoint of sexual desire, as measured by a daily eDiary that recorded the number of sexually satisfying events and asked patients to rate the intensity of desire as “none,” “low,” “moderate,” or “strong.” At the same time, 15% of women taking 100 mg of the drug—the recommended dosage—discontinued treatment due to adverse events such as somnolence, nausea, dizziness, insomnia, and anxiety, compared with 7% of those taking placebo.
The committee’s decision does not mean that the FDA will ultimately reject the new drug application of German manufacturer Boehringer Ingelheim, but approval appears unlikely based on the data reviewed at the committee hearing.
After voting down the drug, Acting Committee Chair Julia Johnson, MD, recommended that Boehringer Ingelheim continue to study the agent because of its “promising” potential—and several other panelists supported that recommendation. Dr. Johnson is Professor and Chair of Obstetrics and Gynecology at the University of Massachusetts Medical School and UMass Memorial Medical Center in Worcester, Mass.
Boehringer Ingelheim is currently recruiting participants for a Phase 3 trial of flibanserin in postmenopausal women in North America (NCT01057901).
When the FDA Advisory Committee for Reproductive Health Drugs convened in mid-June to consider approving the nonhormonal agent flibanserin for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, there was no FDA-approved drug for the disorder.
There still isn’t.
After examining data from two US-based Phase-3 trials (and a third trial conducted in Europe), the committee 1) decided that evidence of flibanserin’s efficacy is lacking, and 2) found the prevalence of side effects worrisome. It did agree with drug maker Boehringer Ingelheim that there is “widespread unmet need” for a medical therapy for HSDD.
The two primary US efficacy studies of flibanserin failed to achieve significance for the prespecified co-primary endpoint of sexual desire, as measured by a daily eDiary that recorded the number of sexually satisfying events and asked patients to rate the intensity of desire as “none,” “low,” “moderate,” or “strong.” At the same time, 15% of women taking 100 mg of the drug—the recommended dosage—discontinued treatment due to adverse events such as somnolence, nausea, dizziness, insomnia, and anxiety, compared with 7% of those taking placebo.
The committee’s decision does not mean that the FDA will ultimately reject the new drug application of German manufacturer Boehringer Ingelheim, but approval appears unlikely based on the data reviewed at the committee hearing.
After voting down the drug, Acting Committee Chair Julia Johnson, MD, recommended that Boehringer Ingelheim continue to study the agent because of its “promising” potential—and several other panelists supported that recommendation. Dr. Johnson is Professor and Chair of Obstetrics and Gynecology at the University of Massachusetts Medical School and UMass Memorial Medical Center in Worcester, Mass.
Boehringer Ingelheim is currently recruiting participants for a Phase 3 trial of flibanserin in postmenopausal women in North America (NCT01057901).
When the FDA Advisory Committee for Reproductive Health Drugs convened in mid-June to consider approving the nonhormonal agent flibanserin for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, there was no FDA-approved drug for the disorder.
There still isn’t.
After examining data from two US-based Phase-3 trials (and a third trial conducted in Europe), the committee 1) decided that evidence of flibanserin’s efficacy is lacking, and 2) found the prevalence of side effects worrisome. It did agree with drug maker Boehringer Ingelheim that there is “widespread unmet need” for a medical therapy for HSDD.
The two primary US efficacy studies of flibanserin failed to achieve significance for the prespecified co-primary endpoint of sexual desire, as measured by a daily eDiary that recorded the number of sexually satisfying events and asked patients to rate the intensity of desire as “none,” “low,” “moderate,” or “strong.” At the same time, 15% of women taking 100 mg of the drug—the recommended dosage—discontinued treatment due to adverse events such as somnolence, nausea, dizziness, insomnia, and anxiety, compared with 7% of those taking placebo.
The committee’s decision does not mean that the FDA will ultimately reject the new drug application of German manufacturer Boehringer Ingelheim, but approval appears unlikely based on the data reviewed at the committee hearing.
After voting down the drug, Acting Committee Chair Julia Johnson, MD, recommended that Boehringer Ingelheim continue to study the agent because of its “promising” potential—and several other panelists supported that recommendation. Dr. Johnson is Professor and Chair of Obstetrics and Gynecology at the University of Massachusetts Medical School and UMass Memorial Medical Center in Worcester, Mass.
Boehringer Ingelheim is currently recruiting participants for a Phase 3 trial of flibanserin in postmenopausal women in North America (NCT01057901).