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News Release - March 12, 2007
Depomed Files Investigational New Drug Application for Gabapentin GR for the Treatment of Postmenopausal Hot FlashesMENLO PARK, Calif.--(HSMN NewsFeed)--Depomed, Inc. (NASDAQ:DEPO ) announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Gabapentin GR(TM) for the treatment of postmenopausal hot flashes. Pending the standard 30-day FDA review period, the company expects to initiate a Phase 2 clinical trial in the second quarter of 2007.
"Our meeting with the FDA regarding Gabapentin GR in postmenopausal hot flashes went well and now, less than three weeks later, we are pleased to have submitted the IND application," said Carl Pelzel, executive vice president and chief operating officer of Depomed. "Gabapentin GR holds the potential to become a new treatment option for the approximately 13 million women in the United States who seek treatment for postmenopausal hot flashes each year. We look forward to working closely with the FDA and to doing all that we can to address this unmet medical need."
The Phase 2, double-blind, placebo-controlled, multi-center trial will involve approximately 110 postmenopausal women experiencing recurrent moderate to severe hot flashes and will be conducted at approximately 15 sites in the United States and Canada. The primary objective of the trial is to determine the optimal dose of Gabapentin GR in reducing the frequency and severity of hot flashes in postmenopausal women. Patients will be randomized into one of four treatment groups, three of which will receive Gabapentin GR and one which will receive placebo. The total study treatment duration after screening and baseline will be 13 weeks. The primary endpoint of the trial is the frequency and severity of hot flashes, relative to baseline. Secondary endpoints include, among others, the efficacy of Gabapentin GR relative to placebo, based on changes from baseline to the end of each treatment period, average daily frequency and severity score of hot flashes, and sleep quality.
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 postmenopausal women support 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.
Formulated with Depomed's proprietary AcuForm(TM) drug delivery technology, Gabapentin GR holds the potential to offer women experiencing postmenopausal hot flashes with the relief benefits provided by immediate release formulations of gabapentin, with fewer side effects and a more convenient dosing regimen. In October 2006, the company announced that it had obtained an exclusive sublicense from PharmaNova, Inc. to a U.S. patent held by the University of Rochester covering the use of gabapentin for the treatment of postmenopausal hot flashes.
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.
Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative AcuForm(TM) drug delivery technology to develop novel oral products and improved, extended release formulations of existing oral drugs. AcuForm-based products are designed to provide once-daily administration and reduced side effects, improving patient convenience, compliance and pharmacokinetic profiles. ProQuin® XR (ciprofloxacin hydrochloride) extended-release tablets have been approved by the FDA for the once-daily treatment of uncomplicated urinary tract infections and are currently being marketed in the United States. In addition, once-daily Glumetza(TM) (metformin hydrochloride extended release tablets) has been approved for use in adults with type 2 diabetes and is currently being marketed in the United States and Canada. The company is conducting a Phase 3 trial in postherpetic neuralgia and has completed a Phase 2 trial in diabetic peripheral neuropathy with its product candidate, Gabapentin GR. Additional information about Depomed may be found at its web site, 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.
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