Panel Gives Thumbs-Down to Depomed's Hot Flash Drug
The modest reduction in menopause-related vasomotor symptoms (VMS) recorded in three Phase III trials was not sufficient to warrant the side-effect risk associated with gabapentin, according to the FDA's Reproductive Health Drugs Advisory Committee, which voted 12-2 Monday to recommend against Depomed Inc.'s Sefelsa (formerly Serada).
In the U.S. and Canada: 1-800-336-4474
Outside the U.S.: 1-215-386-0100
Hours: Monday - Thursday, 8:30 am - 6:00 pm EST
Friday, 8:30am - 4:30 pm EST
Sign up for Perspectives FREE e-mail newsletter