Pfizer Inc.'s pain drug Lyrica has received regulatory approval for treating an estimated 100,000 Americans who have chronic problems associated with spinal cord injuries, the company said today.
Pfizer, which has its largest worldwide research site in Groton, said the U.S. Food and Drug Administration had approved Lyrica for people experiencing neuropathic pain after spinal cord injuries. The company said the pain targeted by Lyrica can be debilitating, hindering rehabilitation efforts and making it difficult to cope with day-to-day life.
"The approval of Lyrica for this indication is a significant milestone, exemplifying Pfizer's commitment to pursue scientific advancements that address unmet medical needs," said Steven J. Romano, head of Pfizer's medicines development group, in a statement.
About 270,000 patients in the United States are dealing with spinal cord injuries, according to Pfizer, and 12,000 new cases are diagnosed every year. About 40 percent of these people suffer from neuropathic pain, which could result from a blow to the spine in a motor vehicle accident, for instance, or might involve a developmental abnormality or the removal of a benign spinal tumor.
The FDA granted Lyrica a priority review because there were no approved treatments in the United States for the sometimes excruciating neuropathic pain associated with spinal cord injuries.