Depomed Completes Enrollment Of Breeze 1 Phase 3 Clinical Trial For Non-Hormonal Treatment In Menopausal Hot Flashes

Main Category: Menopause
Also Included In: Clinical Trials / Drug Trials
Article Date: 04 Mar 2009 - 3:00 PDT

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Depomed, Inc. (NASDAQ:DEPO) announced that it has completed enrollment of Breeze 1, the first of two pivotal Phase 3 clinical trials in Depomed's registration program of DM-5689 for the non-hormonal treatment of menopausal hot flashes.

"We are glad that we achieved this milestone today and look forward to the results of both Breeze 1 and Breeze 2 trials in hot flashes expected later this year. We are well on plan in this important execution year for us," said Carl A. Pelzel, president and chief executive officer of Depomed.

"DM-5689 has the potential to become a significant alternative treatment of hot flashes for the large number of menopausal women in this country. I am glad that we have achieved this milestone in our clinical study today and I would like to convey my thanks to all the Breeze 1 investigators who have made this possible. We look forward to seeing the results later this year," added Dr. Risa Kagan, of East Bay Physicians Medical Group and Clinical Professor, Dept. Ob/Gyn, UCSF, the lead investigator for the Breeze 1 study.

About DM-5689 Clinical Program

Depomed's Phase 3 registration program for DM-5689 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 DM-5689, 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 AcuForm™ 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 DM-5689 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 DM-5689; potential benefits of DM-5689; 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.

Depomed, Inc.