The US Food and Drug Administration (FDA) has accepted the filing of New Drug Application (NDA) for Serada from Depomed, Inc. The agency has also informed the company that the FDA's Reproductive Health Drugs Advisory Committee will discuss the Serada NDA at an Advisory Committee meeting tentatively scheduled for March 4, 2013.
The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013. The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
Serada is Depomed's proprietary extended release formulation of gabapentin in development for the treatment of menopausal hot flashes. Depomed submitted the Serada NDA to FDA on July 31, 2012. Depomed is seeking approval to market and sell Serada in the United States for the treatment of menopausal hot flashes. Serada is an investigational product and is not approved to treat any disease or condition.
"Acceptance of the NDA for Serada and scheduling of an Advisory Committee are important milestones. We believe that Serada may be a viable non-hormonal product candidate for the treatment of menopausal hot flashes, based on our and numerous academic studies that have demonstrated that gabapentin may be effective in treating hot flashes," said Jim Schoeneck, president and CEO of Depomed.
Hot flashes affect 75 per cent of menopausal women or 32 million women in the US annually. Hot flashes are characterized by a sudden, temporary onset of body warmth, flushing and sweating. For those menopausal women who suffer, even small fluctuations in body temperature can cause them to experience profuse sweating or severe chills. Hot flashes are disruptive and impact women's overall quality of life, affecting their mood and their ability to sleep. In fact, insomnia typically worsens with the severity of hot flashes. According to the North American Menopause Society, hot flashes are the most common menopause-related discomfort. For some women, these symptoms can persist for 10 years or more. The exact cause of hot flashes is not known.