Depomed Initiates Second Phase 3 Trial In Menopausal Hot Flashes

Main Category: Menopause
Article Date: 21 Oct 2008 - 9:00 PDT

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Depomed, Inc. (NASDAQ:DEPO) announced today the enrollment and dosing of the first patient in Breeze 2, the second of two pivotal Phase 3 clinical trials in Depomed's registration program for DM-5689 (formerly referred to as Gabapentin GR®) for the treatment of menopausal hot flashes. Breeze 1, the first Phase 3 clinical trial, was initiated in September.

"I look forward to the results of Depomed's Phase 3 trials for DM-5689 in menopausal hot flashes after having seen Depomed's encouraging Phase 2 results. An effective non-hormonal and non-antidepressant treatment alternative would provide great value to patients and physicians," said 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 the lead investigator in the Breeze 2 trial.

Breeze 2 differs from Breeze 1 in its treatment duration, which will be three months for Breeze 2, with assessment of efficacy at 4 and 12 weeks only. Breeze 1's treatment duration will be six months, with primary efficacy endpoints assessed at 4 and 12 weeks, and persistence of efficacy assessed at 6 months as one of the secondary endpoints.

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.