Pfizer releases top-line results from Phase IV trial of fibromyalgia drug Lyrica

The 15-week double-blind, randomized, placebo-controlled Phase IV trial enrolled a total of 107 adolescent patients from multiple centers across the US, Europe and Asia.

This is the first large pharmacological treatment trial to be completed in this study population.

The trial’s primary endpoint was not achieved due to no statistically significant difference between pregabalin and placebo in mean pain score.

Pfizer Global Innovative Pharmaceutical business senior vice-president and head of Global Medicines Development Steve Romano said: "Lyrica has more than 10 years of real world experience supporting the needs of patients and remains an important treatment choice for healthcare professionals.

"These results do not change the established benefit of Lyrica for its approved indications, including fibromyalgia in adults."

The trial was conducted to fulfill a post-marketing commitment required by the US Food and Drug Administration (FDA) when Lyrica was approved to manage fibromyalgia.

The company said that the safety and efficacy of pregabalin in pediatric patients have not been established.

During the trial, medication was administered twice daily and dosing started at 75mg/day and was optimized over a three week period, based on tolerability and response, to a dose of 75mg/day, 150mg/day, 300mg/day or 450mg/day, with the optimized dose maintained for the next 12 weeks.

Currently, Lyrica is approved for various indications in 139 countries and regions across the world.

Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.