NEWARK, Calif., March 4, 2013 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO), a specialty pharmaceutical company, announced today that the Reproductive Health Drugs Advisory Committee (RHDAC) of the U.S. Food and Drug Administration (FDA) voted 2-12 against approval for SEFELSA, Depomed's investigational, oral, twice daily formulation of gabapentin, to treat moderate to severe vasomotor symptoms due to menopause. SEFELSA is the proposed trade name for the medication and was formerly referred to as Serada. Based on the outcome of committee meeting, the company will not have a conference call today as previously indicated.
"Depomed today is a product-focused, growth-oriented specialty pharmaceutical company with a growing franchise of treatments for pain and potentially other CNS indications. With revenues from two marketed products, Gralise and Zipsor, significant royalty income from our partnered products and technology, a strong balance sheet and potential to turn cash flow positive in the second half of this year, we believe that 2013 has the potential to be a landmark year in our company's history," said Jim Schoeneck, President and Chief Executive Officer of Depomed. "We recognize and appreciate the concerns that were raised by the members of the Advisory Committee. Based on today's meeting we believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high. Until we believe there is a positive direction for SEFELSA, we will cease all spending relating to the product candidate."
Data presented at today's Advisory Committee Meeting included results from the Phase 3 clinical program, which enrolled 1706 patients in three studies.
The FDA will consider the Advisory Committee recommendation in its review of the New Drug Application (NDA) for SEFELSA that Depomed submitted on July 31, 2012, though the FDA is not bound to follow it. The Prescription Drug User Fee Act (PDUFA) date for SEFELSA is May 31, 2013. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
About Vasomotor Symptoms
Vasomotor symptoms include hot flashes and night sweats. A hot flash is a sudden flushing and sensation of heat caused by dilation of skin capillaries. Currently, the leading prescription drug product for the treatment of hot flashes associated with menopause is hormone replacement therapy (HRT). HRT involves the administration of the hormone estrogen, either alone or in combination with the hormone progestin.
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 our product candidates, growth of our marketed products 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, 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.