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news.Depomed has completed patient enrollment in the registration phase III trial designed to evaluate the safety and efficacy of Gabapentin GR for the treatment of postherpetic neuralgia.
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In the phase III trial patients have been randomized into one of three treatment groups: Gabapentin GR once-daily, Gabapentin GR twice-daily and placebo. The company expects to announce results from this trial mid-year.
The primary objective of the study is to assess the efficacy of Gabapentin GR compared to placebo in reducing average daily pain scores from baseline to endpoint. Secondary objectives include generating data on safety, sleep interference and general impressions of changes in pain.
Postherpetic neuralgia (PHN) is a persistent neuropathic pain condition caused by nerve damage after a shingles, or herpes zoster, viral infection. Since there is currently no cure for PHN, treatments are focused on relieving pain.
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.