Pfizer’s Lyrica Misses the Mark in Epilepsy Clinical Trial

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Pfizer announced that its Phase III trial evaluating Lyrica (pregabalin) as adjunctive therapy for epilepsy patients with primary generalized tonic-clonic (PGTC) seizures didn’t meet its primary endpoint.

The trial was a Phase III study that lasted 12 weeks. It was a randomized, double-blind, placebo-controlled, multi-center study looking at the efficacy of two different doses of Lyrica in patients ages 5 to 65 with PGTC seizures. Patients were randomized 1:1:1 to receive placebo or 5 mg/kg/day or 10 mg/kg/day, both adjusted appropriately for body weight and age. The trial was run at 70 sites in 21 countries with 219 patients.

The patients receiving Lyrica didn’t show a statistically significant reduction in seizure frequency compared to placebo.

Lyrica is approved in the U.S. as adjunctive therapy for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults. It is also approved as adjunctive therapy for partial onset seizures in patients four years of age and older and for partial onset seizures in patients four years or older with epilepsy who take one or more other drugs for seizures.

“Pfizer is committed to the study of patient populations with unmet treatment needs, including pediatric and adult patients experiencing generalized tonic-clonic seizures,” stated Juan Valle, Global Chief Medical Officer, R&D and Medical, Upjohn, a division of Pfizer. “These data contribute to our growing understanding of pediatric epilepsy and reflect our responsibility to advance scientific knowledge through post-marketing research.”

The Lyrica Pediatric Epilepsy Program is made up of six trials in patients with epilepsy, evaluating the drug as adjunctive therapy. Five have been completed.

On May 15, the company announced positive top-line data from a Phase III trial of abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor in patients with moderate to severe atopic dermatitis (AD). The data showed that by week 12 the proportion of patients hitting each co-primary efficacy endpoint and each key secondary endpoint was significantly higher than placebo.

The co-primary endpoints were the proportion of patients who reached an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin and a greater than 2 point improvement, and the proportion of patients who hit at least a 75% or greater change from baseline in the Eczema Area and Severity Index (EASI) score.

Secondary endpoints were the percentage of patients achieving a 4 point or larger decrease in itch severity measured with the pruritus numerical rating scale (NRS) and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD).

“Moderate to severe atopic dermatitis is a chronic, inflammatory skin disease that can take both a physical and emotional toll on the millions of patients living with the condition worldwide,” stated Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “These top-line findings are encouraging and provide evidence that abrocitinib, if approved, could be an effective new oral once-daily treatment option for patients.”

AD is a chronic skin disease marked by inflammation of the skin. Lesions are characterized by redness, itching, hardening, formation of papules and oozing and crusting. It is one of the most common, chronic, relapsing childhood dermatological diseases.