Depomed Completes Patient Enrollment In Phase 3 Clinical Trial Of Gabapentin Gr In Postherpetic Neuralgia

Announced that it has completed patient enrollment in the pivotal registration Phase 3 clinical trial designed to evaluate the safety and efficacy of Gabapentin GR(TM) for the treatment of postherpetic neuralgia (PHN). The company expects to announce results from this trial mid-year.

MENLO PARK, CA, USA | Mar 08, 2007 |
Depomed, Inc. (NASDAQ:DEPO) today announced that it has completed patient enrollment in the pivotal registration Phase 3 clinical trial designed to evaluate the safety and efficacy of Gabapentin GR(TM) for the treatment of postherpetic neuralgia (PHN). The company expects to announce results from this trial mid-year.

The randomized, double-blind, placebo-controlled Phase 3 clinical trial is being conducted at 110 sites in the United States and has enrolled 407 patients with PHN. Patients have been randomized into one of three treatment groups: Gabapentin GR once-daily, Gabapentin GR twice-daily and placebo. The primary objective of the study is to assess the efficacy of Gabapentin GR administered once-daily and twice-daily (1800 mg total daily-dose) for eight weeks compared to placebo in reducing average daily pain scores from baseline to endpoint. Secondary objectives include generating data on safety, sleep interference and general impressions of changes in pain.

Gabapentin GR is an investigational extended release formulation of gabapentin, an FDA-approved product for the treatment of PHN. Formulated with Depomed's proprietary AcuForm(TM) drug delivery technology, Gabapentin GR holds the potential to offer patients the pain-relief benefits provided by immediate release formulations of gabapentin, with fewer side effects and a more convenient once- or twice-daily dosing regimen. In 2006, 16.3 million prescriptions for gabapentin were dispensed.

About Postherpetic Neuralgia

Neuropathic pain affects approximately 2.6 million individuals in the United States. Postherpetic neuralgia (PHN) is a persistent neuropathic pain condition caused by nerve damage after a shingles, or herpes zoster, viral infection. It afflicts approximately one in five patients diagnosed with shingles, or approximately 150,000 individuals in the United States. The incidence of PHN increases in elderly patients, with 75 percent of those over 70 years old who have shingles, developing PHN. The pain associated with PHN reportedly can be so severe that patients are unable to resume normal activities for months. Since there is currently no cure for PHN, treatments are focused on relieving pain.

About Depomed

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(R) 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(TM). 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 the results and timing of our clinical studies; 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.

SOURCE: Depomed, Inc.

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