Phase 2 Study Of DM-5689 For The Treatment Of Moderate-To-Severe Menopausal Hot Flashes

Main Category: Menopause
Also Included In: Clinical Trials / Drug Trials
Article Date: 26 Sep 2008 - 5:00 PDT

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Depomed, Inc. (Nasdaq:DEPO) announced the presentation of data from its Phase 2 study of DM-5689 (formerly referred to as Gabapentin GR®) for the treatment of women with moderate-to-severe menopausal hot flashes. As previously disclosed, DM-5689 significantly reduced the frequency and severity of hot flashes from baseline to the end of treatment compared to placebo in the 124 patient study.

The data were presented today at the North American Menopause Society (NAMS) Annual Meeting in Orlando, Florida. The poster related to the presentation is available on the company's website.

"We appreciate the opportunity to present the data from our study at NAMS," noted Dr. Michael Sweeney, Depomed's vice president, Product Development. "With the initiation of our Phase 3 program in DM-5689 now underway, we are a step closer to offering physicians and their patients an alternative to hormone therapy and anti-depressants in this area of significant unmet need," Dr. Sweeney added.

About DM-5689

DM-5689 is an investigational, extended release formulation of gabapentin, an FDA-approved drug for the treatment of seizures and postherpetic neuralgia. Published data on the use of gabapentin in menopausal women provide investigational support for the efficacy of the compound to address hot flash symptoms. A study published in the July 2006 issue of Obstetrics & Gynecology reported that gabapentin appeared to be as effective as estrogen in treating hot flashes. In the Position Statement of the North American Menopause Society (NAMS) regarding treatment of menopause-associated vasomotor symptoms (2004), gabapentin is reviewed as a recommended nonhormonal option.

About Hot Flashes

Approximately 80 percent of women in the United States have hot flashes at some level of intensity during perimenopause. 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. The only government-approved single agent therapy in both the United States and Canada for treating this menopause-related symptom is prescription estrogen, which has been associated with increased risk of breast cancer, coronary heart disease, thromboembolism, stroke and dementia.

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 (formerly referred to as Gabapentin GR®) is in clinical development for the treatment of neuropathic pain, and product candidate DM-5689 (formerly referred to as Gabapentin GR®) 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 ofDM-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.