Once in a Day Gralise Reduces Pain in PHN Patients

Depomed, Inc. (NASDAQ: DEPO) today introduced that a report of Phase 3 data posted on the net this month, ahead of the print edition, within the Clinical Journal of Pain confirmed that once-daily Gralise (gabapentin) tablets (1,800 mg) formulation substantially lowers magnitude of discomfort in affected individuals along with postherpetic neuralgia (PHN). The results confirmed that affected individuals treated along with Gralise experienced a major decline in their average daily pain magnitude in comparison to placebo handled affected individuals.

The published achievements came from a randomized, multi-center Phase III clinical study of 452 affected individuals with PHN that tested the efficacy and overall safety of once-daily Gralise in comparison with placebo. Other results showed that this frequency of adverse events frequently related to gabapentin was as shown below: dizziness is 11.3% vs. placebo, 1.7%, somnolence is 5.4% vs. placebo 3.0%, and peripheral edema is 3.2% vs. placebo, 0.4% with differences in dizziness and peripheral edema being statistically large. Secondary endpoints confirmed that 43% of affected individuals taken care of with Gralise reported "much" or "very much" development in comparison with 34% of placebo treated affected individuals.

"Our research has shown that affected individuals treated along with Gralise experienced large alleviation of their daily pain stress level," said Christine N. Sang, MD, MPH, director of Translational Pain Research, Brigham and Women's Hospital, Harvard Medical School. "This discovery is encouraging due to the reason that the pain linked to PHN has a significant influence on patients' daily lives and such results recommend that Gralise, in part due to its gastroretentive formulation, could fill a necessary therapy gap for affected individuals with PHN."

Once-daily Gralise (1800 mg) was well put up within the survey, by having lower incidence of common adverse effects (AEs) than previously confirmed in other gabapentin studies. Within the Phase III study, 210 affected individuals reported AEs, 118 within the Gralise treated population, and 92 in the placebo handled group. The commonest AEs reported came with dizziness, headache and nausea. Ten serious AEs were really reported, four within the Gralise treated group of individuals, and six within the placebo treated group. Not a single one of the SAEs were attributable to the research drug.