Gabapentin Extended Release for the Treatment of Painful Diabetic Peripheral Neuropathy

Abstract

A randomized, double-blind, placebo-controlled study was conducted in 147 patients to determine the efficacy and safety of gabapentin extended release (g-ER) in treating pain associated with diabetic peripheral neuropathy (DPN). Gabapentin, an immediate-release formulation, has demonstrated clinical efficacy in DPN patients but also a relatively high incidence of somnolence and dizziness at the doses required for effective treatment of DPN pain (1,2). Using the polymer-based AcuForm technology, g-ER tablets have been formulated to handle the saturable transport mechanism responsible for the lack of dose proportionality seen with gabapentin. When administered with a meal, g-ER tablets gradually expand and release the drug to the upper gastrointestinal …