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 Thursday.
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.
The FDA approval was expected to give a boost to sales of Lyrica, which last year totaled $3.4 billion, second only to cholesterol pill Lipitor, which has been fading fast after facing generic competition starting late last year.
Lyrica has been prescribed off-label by doctors for patients experiencing nerve pain associated with spinal cord trauma, but some insurance companies have balked at covering the cost of the medicine for a non-approved use. The FDA's approval is expected to alleviate these concerns and boost sales for the pain medication.
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 suffer from neuropathic pain, which could result from a blow to the spine in a motor vehicle accident, for instance, or might involve a 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.
"Given the clinical challenges of investigating neuropathic pain in this patient population, any advancements in treatment are welcome by physicians and patients alike," said Diana Cardenas, chair of department of rehabilitation medicine at the University of Miami Miller School of Medicine and the clinical study investigator, in a statement.
According to the Pfizer study leading to FDA approval of the drug, "more patients receiving Lyrica showed a 30 percent and 50 percent reduction in pain than did patients receiving placebo."
Lyrica also has been approved for use against diabetic nerve pain, pain associated with shingles, fibromyalgia and certain seizures in adults with epilepsy. Pfizer has been looking at several possible new uses for Lyrica.