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Depomed Completes Enrollment in Phase II Clinical Trial in Diabetic Peripheral Neuropathy With Gabapentin GR

Posted on: Thursday, 5 October 2006, 09:00 CDT

Depomed, Inc. (NASDAQ:DEPO) today announced that it has completed enrollment in a Phase II clinical trial to evaluate its Gabapentin GR compound for the treatment of patients with painful diabetic peripheral neuropathy (DPN). The company expects data from the approximately 150-patient trial to be available by year end 2006. This trial is in addition to, and separate from, the pivotal registration Phase III clinical trial that the company is conducting with Gabapentin GR to treat post-herpetic neuralgia.

"We are conducting this trial to gather evidence on the effectiveness of our Gabapentin GR formulation to treat DPN, an indication for which the parent gabapentin compound (Neurontin®) has not been approved in the United States," said Bret Berner, Ph.D., vice president Product Development and chief scientific officer of Depomed, Inc. "We believe our controlled-release formulation, with its unique bioavailability at high dose levels, may provide patients with pain relief which may represent an effective alternative to existing therapies. Establishing safety and efficacy of Gabapentin GR to treat DPN could position our product as an effective gabapentin option for this patient population."

The Phase II clinical trial is a multicenter, double-blind, placebo-controlled study involving approximately 150 patients with diabetic peripheral neuropathy. 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 four-week study is to assess the efficacy of Gabapentin GR in treating DPN. Secondary objectives involve generating data on safety, sleep interference and general impressions of changes in pain.

John Fara, Ph.D., chairman, president and chief executive officer commented, "Gabapentin GR is an exciting product for us, with significant potential in several pain indications as well as other health conditions which represent large target markets. We remain focused on completion of our Phase III clinical trial in post herpetic neuralgia, which is poised as our most rapid path to approval. We anticipate broadening the labeling for Gabapentin GR in DPN with the help of a partner. We believe the potential to add the DPN indication to our initial approval will increase the value of this franchise in the minds of potential partners and strengthen our pharmacoeconomic rationale to the managed care audience. In addition, positive data from our Phase II clinical trial in DPN may offer us an opportunity to leverage our growing presence in the diabetes field, currently represented by our recently-launched Glumetza product, a novel, extended release formulation of metformin for the treatment of Type II diabetes."

About Diabetic Peripheral Neuropathy

Diabetic neuropathy is a peripheral nerve disorder caused by diabetes. Approximately 60 to 70 percent of the 20 million diabetics in the United States have mild to severe forms of nervous system damage. After a period of inadequate glycemic control, nerve damage may occur and may lead to a number of health problems, including indigestion, diarrhea or constipation, dizziness, bladder infections and impotence. DPN is often associated with numbness, pain, or tingling in the feet or legs and may lead to weakness in the muscles of the feet. Current treatment approaches for DPN involve providing options for pain relief and implementing glycemic control measures, including diet, exercise and medication, to prevent further tissue damage by bringing blood sugar levels under control.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative AcuForm™ 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 GlumetzaTM (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 III trial in postherpetic neuralgia 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 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.

Neurontin® is a trademark of Pfizer Inc.

Source: Business Wire

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