By Estel Grace Masangkay
Pfizer posted top-line results from its two studies in China investigating Lyrica (pregabalin) in patients with postherpetic neuralgia (PHN) and painful diabetic peripheral neuropathy (pDPN).
Lyrica is indicated for the treatment of fibromyalgia, for which it received approval in 2007. The drug is also used to treat diabetic nerve pain, spinal cord injury nerve pain, and pain after shingles (PHN). Lyrica is also indicated for the treatment of partial onset seizures in adults with epilepsy who take seizure medication.
PHN is a form of peripheral neuropathic pain stemming from nerve damage. PHN is characterized by electric shock-like or continued burning pain. pDPN is a type of permanent damage to the nerves characterized by shooting, burning, and pins-and-needles pain in the hands and feet.
The eight week, randomized, placebo-controlled, multi-center, double blind, and post marketing PHN Phase 4 study A0081276 achieved its primary endpoint of statistically meaningful reduction in pain compared to placebo. However, the 11-week placebo controlled, double blind, randomized, multicenter pDPN Phase 3 A0081265 study did not meet its primary endpoint of statistically significant change in endpoint mean pain score compared to placebo.
The company said complete results for the two studies will be available for publication once required analyses are completed.
Lyrica is Pfizer’s best selling drug in the U.S. Earlier this year Pfizer won its case to block generic versions of Lyrica until its patent expiration on December 2018. According to the U.S. Court of Appeals for the Federal Circuit in Washington, generic drugmakers — particularly Teva Pharmaceutical and Actavis — would infringe upon the drug’s valid patent if their generic Lyrica versions are released before Pfizer’s patent expiration. Sun Pharmaceutical and Mylan were also included in the case. The case centered on Pfizer’s patent claim (lasting until 2018) on Lyrica’s active ingredient pregabalin and methods to use it to treat pain.