This article is more than 5 years old. Information may no longer be current.

Lyrica misses primary endpoint in phase 4 trial of adolescents with fibromyalgia

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Pfizer announced the primary endpoint was not achieved in a phase 4 trial that evaluated the safety and efficacy of Lyrica Capsules CV in adolescent patients with fibromyalgia, according to a company press release.

The 15-week, double-blind, randomized placebo-controlled trial included 107 adolescent patients with fibromyalgia in the United States, Europe and Asia. No significant differences were seen between patients administered Lyrica Capsules CV (pregabalin, Pfizer) or placebo. The study was intended to meet a post-marketing commitment to the FDA given at the time pregabalin was approved to treat fibromyalgia. Efficacy and safety have not been established for pediatric patients, according to the release.

“Pfizer is committed to better understanding the full clinical profile of our approved medicines in pediatric and adolescent patients,” Steve Romano, MD, senior vice president and head of the Global Medicines Development for the Pfizer Global Innovative Pharmaceutical business, stated in the release. “This study advances the understanding of this patient population.”

Daily pregabalin dosage for patients in the study was 75 mg per day, 150 mg per day, 300 mg per day or 450 mg per day, depending on how well it was tolerated over a 3-week period. Pfizer reported the safety profile observed in the study is consistent with the known profile for pregabalin in prior fibromyalgia studies in adults, with the exception of mild nausea, which occurred at a higher rate in the pregabalin-treated patients. Dizziness, nausea, headache, fatigue and weight gain were the most common adverse events reported by patients in the study.

Pfizer officials noted pregabalin is still approved to treat fibromyalgia in adults.

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

Full results of the study are expected to be published at a later date.

Reference: www.pfizer.com