Depomed Completes Enrollment Of Serada's Full Phase 3 Clinical Program In Menopausal Hot Flashes

Main Category: Menopause
Also Included In: Clinical Trials / Drug Trials
Article Date: 06 Apr 2009 - 2:00 PDT

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Depomed, Inc. (NASDAQ:DEPO) announced that it has completed enrollment of Breeze 2, the second of two pivotal Phase 3 clinical trials of SeradaTM (formerly referred to as DM-5689) for the treatment of menopausal hot flashes.

"I would like to thank all clinical investigators, patients, and Depomed employees whose efforts allowed us to complete enrollment of our full Phase 3 clinical program for Serada. We are encouraged by the level of interest in a non-hormonal alternative treatment for menopausal hot flashes that we noticed during the recruitment of patients. This confirms that there is a significant unmet need existing in the marketplace. We look forward to the results of both of Serada's trials in hot flashes - Breeze 1 and Breeze 2 - which we expect in the fourth quarter of this year," said Carl A. Pelzel, president and chief executive officer of Depomed.

"I am glad to see that Serada is advancing well to potentially become a significant alternative non-hormonal treatment of hot flashes. Physicians and patients are looking for alternatives to today's broadly used hormone replacement therapy and Serada could well address those needs. After having seen Depomed's encouraging Phase 2 results, we look forward to the Phase 3 results later this year," added Wulf Utian, MD PhD DSc, Executive Director and Founder of The North American Menopause Society (NAMS), and Consultant in Women's Health to The Cleveland Clinic. Dr. Utian is also the lead investigator in the Breeze 2 trial.

About Serada's Clinical Program

Depomed's Phase 3 registration program for Serada in menopausal hot flashes includes two randomized, double-blind, placebo-controlled studies of approximately 540 patients per study. The treatment duration of the Breeze 1 study is six months, with primary efficacy endpoints assessed after 4 and 12 weeks of stable treatment. Persistence of efficacy will be assessed at 6 months as one of the secondary endpoints. The treatment duration in the second study, Breeze 2, is three months, also with assessment of efficacy at 4 and 12 weeks. Preliminary top-line data is expected to become available in the fourth quarter 2009 for both studies.

About Menopausal Hot Flashes

Hot flashes, also known as vasomotor symptoms, are sudden waves of heat that can start in the waist or chest and work their way to the neck and face and sometimes over the rest of the body. They are characterized by a sudden, temporary onset of body warmth, flushing and sweating. Depending on the intensity of the hot flash, some women may experience headaches, fatigue, dizziness, or heart palpitations. Each year approximately 32 million women in the United States experience menopausal hot flashes and approximately 13 million of those diagnosed seek treatment. Hormone replacement therapy (HRT) is currently the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes. In 2003, the National Institutes of Health halted a large-scale clinical study of HRT due to preliminary results suggesting a correlation between HRT and an increase risk of breast cancer and cardiovascular disease. Based on these findings and the various side effects associated with HRT, Depomed has secured exclusive rights to develop and commercialize Serada, an AcuForm™-enhanced formulation, for the treatment of menopausal hot flashes.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuFormTM drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. 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. Proquin® XR (ciprofloxacin hydrochloride) is approved in the United States for the once-daily treatment of uncomplicated urinary tract infections and is being marketed in the United States within the urology, Ob/Gyn and long-term care specialties by Watson Pharmaceuticals. Product candidate DM-1796 is in clinical development for the treatment of neuropathic pain and has been licensed to Solvay Pharmaceuticals. Product candidate Serada is in clinical development for menopausal hot flashes. Additional information about Depomed may be found on its website, http://www.depomedinc.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 our clinical development program for Serada; potential benefits of Serada; 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.

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Depomed, Inc.