MENLO PARK, Calif.--(BUSINESS WIRE)--Depomed, Inc. (NASDAQ:DEPO - News) today announced that it has dosed the first patient in a new pivotal registration Phase 3 clinical trial designed to evaluate the safety and efficacy of Gabapentin GR™ for the treatment of postherpetic neuralgia (PHN).
The randomized, double-blind, placebo-controlled Phase 3 clinical trial will enroll approximately 450 patients with PHN. Patients will be randomized into two treatment groups: 1800 mg Gabapentin GR once-daily or placebo. The primary objective of the study is to assess the efficacy of Gabapentin GR in reducing the pain associated with PHN, measured from baseline pain scores to the end of a ten-week stable treatment period on the basis of the Likert pain scale. Secondary objectives include an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life.
“We are excited to move forward with this Phase 3 trial, and are encouraged by the interest from potential development and marketing partners for this Gabapentin GR program in neuropathic pain,” stated Carl A. Pelzel, president and chief executive officer of Depomed, Inc. “We believe that the changes to this new protocol in this study will significantly increase our chances for success.”
This second study follows a previously completed Phase 3 trial of Gabapentin GR in PHN conducted in 2006 and 2007 and is generally consistent with the first Phase 3 clinical trial protocol, with the following primary differences: (a) there is no twice daily active treatment arm in the study, as there was in the prior study; and (b) patients enrolled in the study must have “stable PHN disease” for at least six months, rather than three months, following healing of the shingles rash
The changes in the eligibility criteria resulted from a post hoc analysis that showed that exclusion of patients whose shingles rash had cleared at least three months, but less than six months prior to entry into the study, could have significantly reduced the placebo effect observed in the previous trial.
The new study incorporates statistical advantages relative to the prior study as well. Because the new trial will enroll more patients than the previous trial but with one less active arm, the new study is statistically powered to detect a treatment difference between active and placebo of only 0.4 on the Likert pain scale, whereas the last trial was required to detect a 0.7 difference. In addition, the new trial is required to achieve a statistically significant difference over placebo of at least p = 0.05, rather than the last trial’s higher statistical hurdle of at least p = 0.025.
In July 2007, the company reported results from the first Phase 3 trial. The primary endpoint was not achieved with statistical significance for either active treatment regimen, as compared to placebo, over the ten-week treatment period. However, statistical significance relative to placebo was achieved in each of the first seven weeks for the once-daily treatment arm. Further, the secondary endpoints of sleep interference, Clinical Global Impression of Change (CGIC), a scale used by physicians for overall assessment of patient improvement, and Patient Global Impression of Change (PGIC), a scale used by patients to report their overall assessment of change, were all statistically significant for the once-daily treatment compared to placebo over the ten week study period. The company has therefore concluded that the once-a-day active arm may be a safe and effective treatment for PHN and warrants further study.
About Gabapentin GR
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™ 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 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 is being marketed in Canada by Biovail Corporation. ProQuin® XR (ciprofloxacin hydrochloride) extended release tablets are 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 and Ob/Gyn 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, www.depomedinc.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. The inclusion of forward-looking statements, including those related to expectations regarding our clinical development programs and potential benefits of our products and product candidates, should not be regarded as a representation that any of our plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation, risks and uncertainties related to: 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; our ability to successfully commercialize our products; the success of our collaborative arrangements with development and commercialization partners; and other risks detailed in our filings with the Securities and Exchange Commission filings, including our most recent 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. We undertake no obligation to revise or update this release to reflect events or circumstances that occur after the date of this release.
Contact: Depomed, Inc. Ina Cu, 650-462-5900
Source: Depomed, Inc.
