Depomed Initiates Phase 3 Program In Menopausal Hot Flashes

Main Category: Menopause
Also Included In: Clinical Trials / Drug Trials
Article Date: 19 Sep 2008 - 5:00 PDT

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Depomed, Inc. (NASDAQ:DEPO) announced the enrollment and dosing of the first patient in Breeze 1, the first of two pivotal Phase 3 clinical trials in Depomed's registration program for Gabapentin GR® for the treatment of menopausal hot flashes.

"We believe that Gabapentin GR could become the first single-agent, safe, effective, non-hormonal and non-antidepressant treatment to address menopausal hot flashes, one of the largest unmet needs in women's health. The significant decline in annual prescriptions for hormone replacement treatments by forty million since the Women's Health Initiative trials were stopped in 2002 speaks to that need," said Michael Sweeney, M.D., Depomed's vice president, Product Development.

Carl A. Pelzel, president and chief executive officer of Depomed, added, "With Gabapentin GR's potential for a high degree of unique differentiation versus the standard of care and its patent exclusivity, these Phase 3 clinical trials represent a major step toward building the value of our late-stage pipeline."

Depomed's Phase 3 registration program for Gabapentin GR in menopausal hot flashes includes two randomized, double-blind, placebo-controlled studies of approximately 540 patients per study. In each study, patients will be randomized into one of three treatment arms - the first group receives placebo; the second group 1200mg of Gabapentin GR dosed once daily; and the third group a total dose of 1800mg of Gabapentin GR dosed 600mg in the morning and 1200mg in the evening. The primary efficacy endpoints in both studies will be reductions in the mean frequency of moderate-to-severe hot flashes, and the average severity of hot flashes, measured after 4 and 12 weeks of stable treatment. Various secondary efficacy endpoints including quality of life will be measured as well.

The treatment duration of the Breeze 1 study will be six months, with primary efficacy endpoints assessed at 4 and 12 weeks. Persistence of efficacy will be assessed at 6 months as one of the secondary endpoints. The treatment duration in the second study, Breeze 2, will be three months, with assessment of efficacy at 4 and 12 weeks only. Breeze 2 is expected to begin in the fourth quarter.

About Gabapentin Use in Hot Flashes

Gabapentin GR 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 extended release tablets) 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 Gabapentin GR® is currently in clinical development for the treatment of neuropathic pain and 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 Gabapentin GR; potential benefits of Gabapentin GR; 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.