FDA accepts DepoMed's hot-flash drug for review
MENLO PARK, Calif. (AP) — 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 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 condition.
The company said hot flashes affect about 75 percent of menopausal women, or 32 million people in the U.S., and can affect a woman's mood, ability to sleep and quality of life. They are characterized by sudden flushing and sweating.
Shares of DepoMed rose 23 cents, or 3.8 percent, to $6.28 in afternoon trading. The stock is down 15 percent from its 52-week high of $7.15 set in early February. It fell to a 52-week low of $4.20 last November.