GraliseTreatment for Postherpetic Neuralgia
Update: Gralise (gabapentin) Now FDA Approved - January 28, 2011
FDA Accepts DM-1796 NDA
Depomed Announces Acceptance of New Drug Application for Investigational Postherpetic Neuralgia Treatment DM-1796
MENLO PARK, Calif., Jun 7, 2010 (GlobeNewswire via COMTEX) --Depomed, Inc. today announced that the New Drug Application (NDA) for DM-1796 was accepted by the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.
"We are pleased the NDA was accepted for DM-1796. The acceptance triggers a $10 million milestone payment from our licensee," said Carl Pelzel, president and chief executive officer of Depomed. "We look forward to the approval of DM-1796, which we believe can provide significant clinical benefits to patients."
About Postherpetic Neuralgia
Postherpetic neuralgia (PHN) is a persistent neuropathic pain condition. It is caused by nerve damage after shingles, or herpes zoster, viral infection. Approximately 70,000 to 100,000 Americans are affected by PHN each year. The incidence of PHN increases in elderly patients -- 35 percent of shingles patients over 80 years old develop PHN. The pain associated with PHN can interfere with daily activities such as sleep and recreational activities and can be associated with clinical depression.
About DM-1796 (gabapentin extended release) Tablets
DM-1796 is an investigational, once-daily therapy for the management of postherpetic neuralgia. It features a unique extended release formulation which allows for the drug to be gradually absorbed into the blood. This reduces the frequency of peak concentrations commonly seen with immediate release formulations currently on the market. A reduction in the frequency of peak concentrations may result in a lower incidence of side effects. The formulation and the evening dosing regimen will allow for greater exposure of the drug during the night when patients with postherpetic neuralgia report the most pain. Treatment tolerability and a convenient dosing regimen could potentially translate into greater patient compliance and ultimately better pain management.
The NDA follows the completion of a randomized, double-blind, placebo-controlled Phase 3 study of 452 PHN patients. The study demonstrated that DM-1796 achieved a statistically significant reduction in average daily pain score associated with PHN versus placebo using the numerical Likert pain scale.
Abbott Products, Inc. (formerly Solvay Pharmaceuticals, Inc.) has licensed the rights to DM-1796 from Depomed in the U.S., Canada and Mexico for the treatment of pain. Abbott Products, Inc. is a wholly-owned subsidiary of Abbott Laboratories.
The DM-1796 NDA was submitted under Section 505(b)(2) of the Food, Drug and Cosmetic Act because it references certain toxicity, safety and other data of Neurontin, the immediate release formulation of gabapentin initially approved by the FDA. Depomed has filed a Current Report on Form 8-K with the Securities and Exchange Commission describing the 505(b)(2) regulatory pathway applicable to DM-1796 in light of patents listed in the FDA's Orange Book publication for Neurontin.
Depomed, Inc. is a specialty pharmaceutical company with one product candidate through Phase 3 clinical development, another in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 has completed Phase 3 clinical development and has been licensed to Abbott Products, Inc. Product candidate SeradaTM is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA(R) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology, which is designed 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. Additional information about Depomed may be found on its website, www.depomed.com.
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"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-1796; potential benefits of DM-1796; our collaboration with Abbott Products, Inc. related to DM-1796; the market potential for DM-1796; 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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SOURCE: Depomed, Inc.
CONTACT: Depomed, Inc. Sheilah Serradell (650) 462-5900 firstname.lastname@example.org
Posted: June 2010
- Depomed Announces US Food and Drug Administration Approval of Gralise (gabapentin) Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia - January 31, 2011
- Depomed Announces Submission of New Drug Application for Investigational Postherpetic Neuralgia Treatment DM-1796 - March 31, 2010