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news.Depomed has released results showing the efficacy benefits of its Gabapentin GR tablets for the once daily treatment of pain in patients with diabetic peripheral neuropathy, a nerve disorder caused by diabetes.
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“We attribute these strong safety and efficacy results to our unique formulation of gabapentin which is based on our AcuForm drug delivery technology,” said Carl Pelzel, executive vice president of Depomed.
The primary objective of the four-week study was to assess the efficacy of Gabapentin GR in treating the pain associated with diabetic peripheral neuropathy (DPN).
Reductions in average daily pain scores from baseline to the end of treatment based on the 11 point Likert pain scale were statistically significant with once daily Gabapentin GR. Clinically significant improvements in the pain score were observed with a mean change from baseline to study end of -2.45 compared to -1.26 for placebo.
Although not statistically significantly different for twice daily Gabapentin GR, there was pain improvement with a reduction in mean daily pain score of -1.75 with Gabapentin GR compared to -1.26 with placebo.
“The pharmacodynamic properties of Gabapentin GR provide long lasting drug exposure to help manage the pain. This is especially important with Gabapentin GR given once daily with an evening meal as pain is generally more pronounced in patients at night.
“Patients are being dosed at what appears to be an optimal time with a controlled release formulation that provides extended pain relief throughout the day,” said Sherwyn Schwartz, director, Diabetes & Glandular Disease Research Associates of San Antonio.