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News Release - May 10, 2006
Depomed Finalizes Phase III Clinical Trial Protocol for Gabapentin GR(TM)MENLO PARK, Calif.--(HSMN NewsFeed)--May 10, 2006--Depomed, Inc. (NASDAQ:DEPO ) today announced that it has finalized the Phase III clinical trial protocol for Gabapentin GR(TM) in conformance with requirements from the United States Food and Drug Administration (FDA). Gabapentin GR extended release tablets are in development for the treatment of postherpetic neuralgia (PHN), a long lasting pain condition caused by nerve damage during a shingles, or herpes zoster, viral infection. The company expects to begin enrollment later this month.
"We are pleased to have definition on the registration requirements for our Gabapentin GR product," said John Fara, Ph.D., chairman, president and chief executive officer of Depomed. "We look forward to conducting this trial, and with positive data, we plan to file our New Drug Application with the FDA."
The randomized, double-blind, placebo-controlled study will include approximately 400 patients with postherpetic neuralgia. The primary goal is to evaluate 1800 mg twice-daily Gabapentin GR compared to placebo, as well as an arm to evaluate once-daily Gabapentin GR against placebo. Each patient will receive the 1800 mg dose for 8 weeks and the primary end point for the study will be a reduction in pain score as measured from baseline using the Likert pain scale, a numerical rating to assess pain intensity. A secondary endpoint, among others, will be a measurement of sleep interference, a common issue if patients experience breakthrough pain during the night. The trial will involve approximately 75 centers across the United States.
Earlier this year, the company reported results from its Phase II trial with Gabapentin GR, which closely mirrors the Phase III clinical trial protocol, but was shorter in duration. In the Phase II trial in 158 patients with PHN, reductions in average daily pain scores were statistically significant with twice-daily Gabapentin GR from week two to the end of treatment based on the Likert pain scale. Clinically significant improvements in the score were observed with mean change from baseline to study end of -2.24 compared to -1.29 for placebo (p= 0.014). The secondary endpoint of sleep interference was also statistically significantly different with Sleep Interference Scores reduced by -2.28 with Gabapentin GR compared to -1.16 with placebo (p=.006). In addition, in the Clinical Global Impression of Change, a scale used by physicians for overall assessment of patient improvement, 52.3% of patients taking Gabapentin GR twice daily were "very much improved" or "much improved" compared to only 25% of the patients who received placebo. For once daily Gabapentin GR, there was also a trend in pain improvement.
There were no serious adverse events associated with Gabapentin GR. The most common side effect observed was dizziness, which is commonly associated with gabapentin.
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) once daily, extended-release tablets have been approved by the FDA for the treatment of uncomplicated urinary tract infections. In addition, regulatory applications for once daily Glumetza(TM) for the treatment of Type II diabetes have been approved in the U.S. and Canada. The company completed a Phase II trial in post herpetic neuralgia 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 expectations regarding enrollment in clinical trials, 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. 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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