FDA approves vaginal insert to treat dyspareunia in menopause

 

Prasterone (Intrarosa), a vaginal insert containing dehydroepiandrosterone (DHEA) to treat dyspareunia in menopause caused by vulvar and vaginal atrophy, has won Food and Drug Administration approval.

It’s the first FDA-approved product containing the active ingredient prasterone, known also as DHEA. It will be marketed by Endoceutics Inc., a Quebec-based pharmaceutical company focused on women’s health.

Moderate to severe pain during sexual intercourse is a frequent symptom of vulvar and vaginal atrophy (VVA) in menopause. “Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA,” Audrey Gassman, MD, of the FDA’s Center for Drug Evaluation and Research, said in a Nov. 17 statement announcing the approval.

The approval is based on the results of two 12-week placebo-controlled trials of 406 healthy, postmenopausal women, ranging in age from 40 to 80 years, who identified dyspareunia as their most bothersome symptom of VVA. During the trials, prasterone reduced the severity of pain experienced during sexual intercourse, when compared with placebo. Safety of the treatment was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse events were vaginal discharge and abnormal Pap smear, according to the FDA.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

 

Prasterone (Intrarosa), a vaginal insert containing dehydroepiandrosterone (DHEA) to treat dyspareunia in menopause caused by vulvar and vaginal atrophy, has won Food and Drug Administration approval.

It’s the first FDA-approved product containing the active ingredient prasterone, known also as DHEA. It will be marketed by Endoceutics Inc., a Quebec-based pharmaceutical company focused on women’s health.

Moderate to severe pain during sexual intercourse is a frequent symptom of vulvar and vaginal atrophy (VVA) in menopause. “Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA,” Audrey Gassman, MD, of the FDA’s Center for Drug Evaluation and Research, said in a Nov. 17 statement announcing the approval.

The approval is based on the results of two 12-week placebo-controlled trials of 406 healthy, postmenopausal women, ranging in age from 40 to 80 years, who identified dyspareunia as their most bothersome symptom of VVA. During the trials, prasterone reduced the severity of pain experienced during sexual intercourse, when compared with placebo. Safety of the treatment was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse events were vaginal discharge and abnormal Pap smear, according to the FDA.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

 

Prasterone (Intrarosa), a vaginal insert containing dehydroepiandrosterone (DHEA) to treat dyspareunia in menopause caused by vulvar and vaginal atrophy, has won Food and Drug Administration approval.

It’s the first FDA-approved product containing the active ingredient prasterone, known also as DHEA. It will be marketed by Endoceutics Inc., a Quebec-based pharmaceutical company focused on women’s health.

Moderate to severe pain during sexual intercourse is a frequent symptom of vulvar and vaginal atrophy (VVA) in menopause. “Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA,” Audrey Gassman, MD, of the FDA’s Center for Drug Evaluation and Research, said in a Nov. 17 statement announcing the approval.

The approval is based on the results of two 12-week placebo-controlled trials of 406 healthy, postmenopausal women, ranging in age from 40 to 80 years, who identified dyspareunia as their most bothersome symptom of VVA. During the trials, prasterone reduced the severity of pain experienced during sexual intercourse, when compared with placebo. Safety of the treatment was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse events were vaginal discharge and abnormal Pap smear, according to the FDA.

mschneider@frontlinemedcom.com

On Twitter @maryellenny