DEPOMED COMPLETES ENROLLMENT IN TRIAL OF GABAPENTIN IN DPN

Depomed 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 the end of 2006. This trial is in addition to, and separate from, the Phase III clinical trial that the company is conducting with Gabapentin GR to treat post-herpetic neuralgia.

"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," said Bret Berner, vice president and chief scientific officer of Depomed

The Phase II clinical trial is a multicenter, double-blind, placebo-controlled study involving approximately 150 patients with DPN. 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.

Diabetic neuropathy is a peripheral nerve disorder caused by diabetes. 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 to prevent further tissue damage.