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Phase 2 Trial Initiated To Evaluate Safety, Efficacy of Gabapentin in patients with Postherpetic Neuralgia
"We are excited to have another product enter advanced-stage clinical testing," said John W. Fara, Ph.D., chairman and chief executive officer of Depomed. "With two products currently under review at the FDA and nearing commercialization, we understand the importance of a steady steam of programs which can expand our product offerings and continue to build shareholder value."
The randomized, double-blind, placebo controlled trial is expected to include approximately 25 U.S. sites and 150 postherpetic neuralgia patients. The primary objective is to assess the efficacy of Gabapentin ER twice daily compared to placebo in reducing mean daily pain scores. In addition, the trial will evaluate other safety and efficacy parameters, including sleep interference, a common problem of patients in pain.
"From this trial, we will gather data on Gabapentin ER's ability to provide extended pain relief, with less frequent dosing, to patients suffering from this chronic pain condition," said Bret Berner, Ph.D., vice president, Product Development. "This is particularly important to provide a more patient-friendly regimen that allows patients to stay ahead of the pain."
In a Phase I trial involving 15 healthy volunteers, pharmacokinetic properties of Gabapentin ER were compared to Neurontin, Pfizer's brand of gabapentin. The data showed that Gabapentin ER has an extended, sustained release plasma profile that is appropriate for administration twice daily compared to the most commonly prescribed three times daily dosing with Neurontin.
Postherpetic neuralgia (PHN) is a persistent pain condition caused by nerve damage during a shingles, or herpes zoster, viral infection. PHN afflicts approximately one in five patients diagnosed with shingles. The incidence increases in elderly patients with 75 percent of those over 70 years old 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 no cure for PHN, treatments are focused on relieving pain.
Source: Depomed, Inc.