Pfizer Pain Med Lyrica Flunks Post Market Study in Adolescents
Published: Mar 13, 2015
March 13, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Global biopharmaceutical company Pfizer Inc. announced today that its pain medication Lyrica did not meet its primary endpoint in a Phase IV study. Lyrica, also known as pregabalin, was being tested for safety and efficacy in adolescents between the ages of 12 and 17 with fibromyalgia. The drug did not show any significant difference compared to a placebo.
"Pfizer is committed to better understanding the full clinical profile of our approved medicines in pediatric and adolescent patients,” said Steve Romano, senior vice president and head of the Global Medicines Development for Pfizer Global Innovative Pharmaceutical. “This study advances the understanding of this patient population. 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."
During the 15-week, double blind, randomized study, 107 adolescents were observed to determine how they reacted to Lyrica compared to a placebo. There was 0.66-point difference between the drug and the placebo in mean pain score. This was not statistically significant enough for the researchers to say the drug had met its primary endpoint.
The study was held to fulfill a post-marketing commitment required by the U.S. Food and Drug Administration (FDA).
Patent Extension Keeps Lyrica with Pfizer
Pfizer learned on Feb. 6 that the U.S. Appeals court had upheld two patents on Lyrica, which were set to expire. Now, Pfizer will have the patents on the drug until Dec. 30, 2018.
The two patents in the lawsuit were U.S. Patent No. 6,197,819, which covers the active ingredient pregabalin, and U.S. Patent No. RE 41,920, which covers methods for using pregabalin to treat pain. Pfizer and Northwestern University have the rights to pregabalin, the active ingredient in Lyrica. As a result of the ruling, generic drug makers will need to wait a few more years to obtain the ingredient for a non-brand version of Lyrica.
“We are pleased with today’s decision by the Court of Appeals for the Federal Circuit ensuring B>Pfizer/B> will exclusively provide pregabalin as Lyrica to patients through December 30, 2018 in the U.S., pending a possible rehearing or appeal of this decision and pending other litigation,” said Michael Parini, senior vice president and associate general counsel for Pfizer.
BioSpace Temperature Poll
Vertex Pharmaceuticals made news last week when it terminated leases on three properties in Cambridge, Mass, that freed up 313,000 square feet of space in the Genetown area. The company has spent a significant part of 2014 consolidating its operations on the South Boston waterfront, leasing 291,000 square feet of office space at West Kendall Street in Cambridge’s Kendall Square. So we wanted to ask the BioSpace community: Is Boston going to be getting more biotech leases anytime soon, or fewer tenants?