Depomed, Inc. Announces Serada® NDA Acceptance and FDA Advisory Committee Meeting
Published: Oct 15, 2012
MENLO PARK, Calif., Oct. 15, 2012 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO) today announced that its New Drug Application (NDA) for Serada® has been accepted for filing by the U.S. Food and Drug Administration (FDA). In addition, the FDA has 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.
About Menopausal Hot Flashes
Hot flashes affect 75% of menopausal women or 32 million women in the U.S. 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.
Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to regulatory approval of product candidates and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2011 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2012. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
August J. Moretti
SOURCE Depomed, Inc.