FDA Issues Complete Response Letter on SEFELSA™ New Drug Application
NEWARK, Calif., May 31, 2013 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to the New Drug Application for SEFELSA, Depomed's investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause.
The CRL states that the FDA cannot approve the application in its present form. Based on the letter, Depomed does not currently intend to further invest in SEFELSA.
"The CRL was expected in light of the SEFELSA FDA Advisory Committee meeting," said Jim Schoeneck, President and Chief Executive Officer. "Depomed today is a product-focused, growth-oriented specialty pharmaceutical company 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."
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 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 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2013. 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.