A phase 3 study showed that Pfizer's pregabalin controlled-release formulation holds promise in adult patients with postherpetic neuralgia, the manufacturer announced in a press release.
A phase 3 study showed that Pfizer’s pregabalin controlled-release (CR) formulation holds promise in adult patients with postherpetic neuralgia (PHN), the manufacturer announced in a press release.
The double-blind, randomized, placebo-controlled study compared the safety and efficacy of pregabalin CR with placebo in treating shingles pain among patients who initially responded to single-blind pregabalin treatment.
According to Pfizer, 796 patients with PHN initially participated in the trial’s single-blind phase, and 418 of them exhibited at least a 50% reduction in pain compared with baseline and were then enrolled into the trial’s double-blind phase.
The primary endpoint of the double-blind phase was the time to loss of therapeutic response in pain reduction, defined as a <30% pain response relative to the baseline mean pain or withdrawal due to lack of efficacy or adverse effects. This endpoint occurred in 13.9% of patients in the pregabalin group, compared with 30.7% of patients in the placebo group, according to the press release.
Pfizer also reported that the drug was well tolerated and its safety profile was consistent with the known profile of immediate-release pregabalin (Lyrica) in PHN patients. The most common adverse events of pregabalin CR were dizziness, somnolence, peripheral edema, and weight increase.
The full results of the study will be submitted for publication once the analyses are complete, Pfizer announced.