FDA approves gabapentin once-daily for post-herpetic neuralgia

FDA has approved gabapentin (Gralise, Depomed and Abbott Products) tablets for once-daily treatment of post-herpetic neuralgia (PHN). Post-herpetic neuralgia is a painful and often quite debilitating condition, particularly impactful among the elderly population, according to Formulary Clinical Editor David Calabrese, RPh, MHP.

“The approval of Gralise provides clinicians and patients with yet another important treatment option for the management of PHN,” said Calabrese, chief clinical officer, Med Metrics Health Partners, Worcester, Mass. “Gralise’s key features include a favorable dosing, pharmacokinetic, and adverse event profile, without a controlled substance designation. Its primary challenge, however, will be the ability to clearly distinguish the clinical significance and cost-benefit of these features versus generic gabapentin within the managed care setting.”

FDA previously granted Gralise orphan drug status for the treatment of PHN.

Gralise was approved on the basis of 2 phase 3 trials involving 359 patients treated with Gralise and 364 treated with placebo. Safety was evaluated in all 723 patients and the efficacy assessment was based on the second phase 3 trial, a randomized, double-blind, placebo-controlled study of 452 PHN patients. In this trial, Gralise achieved a statistically significant reduction in average daily pain score compared to placebo. Patients in the study were randomly assigned into 2 treatment arms: placebo or 1,800 mg of Gralise dosed once daily.

A total of 359 patients with PHN have received Gralise at doses up to 1,800 mg once daily during placebo-controlled clinical studies. In these trials, 9.7% of patients treated with Gralise and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the Gralise treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of Gralise-treated patients who experienced adverse reactions, the majority of those adverse reactions were either “mild” or “moderate.”

Gralise is to be titrated over a 2-week period to an 1,800-mgonce-daily dose, given with the evening meal. The manufacturer currently expects Gralise will be available in 300-mg and 600-mg tablets later this year.