NEW YORK — The Food and Drug Administration has approved a new indication for a Pfizer drug.
Lyrica (pregabalin) capsules CV now can be used for the management of neuropathic pain associated with spinal cord injury. The drug received a priority review designation for this new indication as more than 100,000 patients — approximately 40% of the 270,000 patients with spinal cord injury in the United States — suffer from this chronic, complex pain condition.
Lyrica is indicated for use in treating fibromyalgia, diabetic nerve pain, pain after shingles and partial onset seizures in adults with epilepsy. In December 2011, Pfizer released late-stage clinical trial results that indicated that the use of Lyrica produced a "significant" benefit in patients with restless legs syndrome.
“Until now, no FDA approved treatment options were available in the U.S. for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling,” said Steven Romano, SVP and head of the medicines development group for Pfizer's global primary care business unit. “The approval of Lyrica for this indication is a significant milestone, exemplifying Pfizer’s commitment to pursue scientific advancements that address unmet medical needs.”