updated 3/3/2011 4:15:23 AM ET 2011-03-03T09:15:23

MENLO PARK, Calif., March 3, 2011 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) announced today that it has completed enrollment of Breeze 3, the company's pivotal Phase 3 clinical trial evaluating Serada® (extended release gabapentin tablets) for the non-hormonal treatment of menopausal hot flashes.

"We are pleased to reach this important milestone in Serada's development. We continue to expect Breeze 3 will be successful based on our study design, and look forward to reporting results in the fourth quarter of this year," said Carl A. Pelzel, president and chief executive officer of Depomed.

"We appreciate the efforts of all the investigators and others who have made this possible," added Dr. Mike Sweeney, Depomed's vice president, Research and Development.

Breeze 3 Trial Design

Breeze 3 is a randomized, double-blind, placebo-controlled study of approximately 600 patients. Patients have been randomized into one of two treatment arms, with patients receiving either placebo or a total dose of 1800mg of Serada dosed 600mg in the morning and 1200mg in the evening. The co-primary efficacy endpoints in the study will be reductions in the mean frequency of moderate-to-severe hot flashes, and the average severity of hot flashes, measured after four and 12 weeks of stable treatment. The treatment duration of the study will be 24 weeks, to address the FDA's view that an effective drug should also demonstrate persistence of efficacy at 24 weeks.

Breeze 3 is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. An SPA is an agreement with the FDA that a proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support a product candidate's regulatory approval.

About Menopausal Hot Flashes

Hot flashes, which affect 32 million women in the U.S. annually, are characterized by a sudden, temporary onset of body warmth, flushing and sweating. 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. Research suggests hot flashes occur when the body's internal thermoregulatory mechanism (located in the hypothalamus) becomes irregular, narrowing the body's thermoneutral zone. Thus, even small fluctuations in body temperature can cause menopausal women to experience profuse sweating or severe chills that would not affect a person with a properly functioning thermoregulatory mechanism.

About Serada

Serada is an extended-release formulation of gabapentin for the treatment of menopausal hot flashes using Depomed's proprietary Acuform® drug delivery technology. By combining gabapentin with Acuform technology, Serada is absorbed slowly into the upper gastrointestinal tract over several hours rather than immediately. Immediate release formulations of gabapentin have been approved by the FDA to treat neuropathic pain and epilepsy.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and has developed another approved product. GRALISETM (gabapentin) is a once-daily treatment approved in the United States for management of post-herpetic neuralgia (PHN) and has been licensed to Abbott Products, Inc. GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. The company also has a robust pipeline including one in Phase 3 clinical development, and other product candidates in its early stage pipeline. Product candidate Serada® is in Phase 3 clinical development for menopausal hot flashes. 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 controlled release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, http://www.depomed.com.

The Depomed, Inc. logo is available athttp:// www.globenewswire.com/newsroom/prs/?pkgid=7529

"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 the results of Breeze 3; our clinical development programs; our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. 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.

CONTACT: Sheilah Serradell
         Depomed, Inc.

© Copyright 2012, GlobeNewswire, Inc. All Rights Reserved


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