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Gabapentin Reduces Pain of Postherpetic Neuralgia in Phase 3 Trial
The double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of a gastroretentive formulation of Gralise (1,800 mg once daily) in 452 patients with postherpetic neuralgia. All of the patients had persistent pain for at least 6 months but not for more than 5 years after the healing of a herpes zoster rash, with a pain intensity score of at least 4 on the 11-point Numerical Rating Scale (NRS) at screening.
In a secondary endpoint, 43% of patients treated with Gralise reported "much" or "very much" improvement compared with 34% of placebo-treated patients (P
The rates of adverse events commonly associated with gabapentin compared with placebo were as follows: dizziness (11.3% vs. 1.7%), somnolence (5.4% vs. 3.0%), and peripheral edema (3.2% vs. 0.4%). The differences in dizziness and peripheral edema were statistically significant.
Each year, approximately one million Americans develop shingles, a painful viral infection caused by reactivation of the virus that causes chickenpox. It is estimated that up to 20% of people with shingles will experience prolonged pain after the infection––a condition known as postherpetic neuralgia. The pain can persist long after the shingles rash has healed and can disrupt sleep, mood, work, and other daily activities.
For more information, here's the news release from Depomed.