Gabapentin Extended Release for the Treatment of Painful Diabetic Peripheral Neuropathy
Efficacy and tolerability in a double-blind, randomized, controlled clinical trial
- David Sandercock, MD1,
- Marilou Cramer2,
- Jacqueline Wu, PHD2,
- Yu-Kun Chiang, PHD3,
- Victor Biton, MD4 and
- Michelle Heritier, PHD2
- 1North San Antonio Healthcare, San Antonio, Texas
- 2Depomed, Inc., Menlo Park, California
- 3Essence Sciences, San Jose, California
- 4Clinical Trials, Inc., Little Rock, Arkansas
- Corresponding author: Michelle Heritier, mheritier{at}depomedinc.com
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 …
