Once-daily Gralise significantly reduces pain intensity in PHN patients

Depomed, Inc. announced that a report of Phase 3 data published online this month, ahead of the print edition,  in the Clinical Journal of Pain showed that once-daily Gralise^® (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN). The results showed that patients treated with Gralise experienced a significant reduction (- 2.12) in their average daily pain intensity compared with placebo treated patients (-1.63; P=0.013). This difference from placebo was statistically significant after one week and continued to be superior through the duration of the study. 

About Gralise (below structure-Gabapentin) : Gabapentin (brand names Fanatrex, Gabarone, Gralise, Neurontin, Nupentin) is a pharmaceutical drug, specifically a GABA analogue. It was originally developed for the treatment of epilepsy, and currently is also used to relieve neuropathic pain. There are, however, concerns regarding the quality of the trials conducted.

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GSK and XenoPort receive FDA approval for Horizant® for postherpetic neuralgia

GlaxoSmithKline plc  and XenoPort, Inc. announced today that the United States (US) Food and Drug Administration (FDA) has approved Horizant® (gabapentin enacarbil see structure below) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults. 

 The efficacy and safety of Horizant for the management of PHN was evaluated in a single 12-week principal efficacy trial, plus two supportive studies that all met their respective primary endpoints. The three clinical studies involved 574 adult patients from the US, Canada and Germany. 

The recommended dosage for the management of PHN in adults is 600 mg twice daily. Treatment should be initiated at a dose of 600 mg in the morning for three days followed by 600 mg twice daily (1,200 mg/day) beginning on day four. Doses must be adjusted in patients with impaired renal function. In the 12-week, controlled study in patients with PHN, somnolence and dizziness were the most frequently reported side effects. Somnolence was reported in 10% of patients treated with 1,200 mg of Horizant per day compared with 8% of patients receiving placebo. Dizziness was reported in 17% of patients receiving 1,200 mg of Horizant per day compared with 15% of patients receiving placebo.

GSK and XenoPort receive FDA approval for Horizant® for postherpetic neuralgia