Positive Phase III Trial Results Reported for Serada Non-Hormonal Therapy for Menopausal Hot Flashes

Positive results from two Phase III clinical trials testing Serada, a non-hormonal extended release medication to treat menopausal hot flashes, were released by Depomed Inc. October 12, 2009.

Two different doses of Serada were evaluated in the trials, with patients receiving 1800mg or 1200mg of the medication. Both doses revealed a significant reduction in the severity and frequency of menopausal hot flashes when compared to a placebo at the end of the study, which concluded at two different endpoints following four weeks and 12 weeks of treatment.

“We are pleased to see that the 1800mg dose clearly demonstrated Serada’s efficacy at four weeks while the lower 1200mg dose at four weeks achieved three of the four co-primary endpoints.” said Dr. Michael Sweeney, vice president of research and development for Depomed. “We need to extensively analyze the data to better understand all of the implications in order to refine our approach to any additional development.”

In the clinical trial, 1,100 patients were randomly placed into three different groups with one group receiving a placebo, a second receiving 1200mg SeradaTM once daily, and the final group receiving 1800mg two times a day.

“We remain very enthusiastic about Serada and our menopausal hot flash program,” said Carol Pelzel, president and chief executive officer of Depomed. “There is a large unmet need for a non-hormonal hot flash therapy, and we believe Serada has the potential to address that need.”

Hot flashes associated with menopause affect 32 million women in the United States each year.

The medication was generally well tolerated by patients in the studies with side effects typically limited to dizziness and drowsiness.

“We look forward to meeting with the FDA later this quarter to discuss these results, the path to approval and any additional clinical work that may be required,” said Pelzel.