FDA accepts Depomed's hot flash drug for review
MENLO PARK, Calif. -- The Food and Drug Administration will review Depomed Inc.'s potential treatment for menopausal hot flashes and may decide its fate by next spring.
Depomed, based in Menlo Park, Calif., said Monday that the FDA accepted Serada for a standard review and aims to complete its evaluation by May 31. Depomed had submitted the drug's application to regulators on July 31.
Serada is an extended-release form of gabapentin, a drug used to treat epilepsy and pain disorders, and it has yet to be approved to treat any conditions.
The company said hot flashes affect about 75 percent of menopausal women, or 32 million people in the United States, and can affect a woman's mood, ability to sleep and quality of life. They are characterized by sudden flushing and sweating.
Its shares closed at $6.05 on Friday. Its shares are down 15 percent from their 52-week high of $7.15 set in early February. They fell to a low for the year of $4.20 last November.