Pfizer Inc (PFE) Thursday announced that U.S. Food and Drug Administration, or the FDA, has granted approval for the use of Lyrica capsules for the management of neutopathic pain associated with spinal cord injury.
The company stated that Lyrica has been given priority review designation by the FDA for the new indication.
Pfizer further stated that neuropathic pain can be experienced above, at or below the level of the spinal cord injury, and is typically not confined to one area in the body. Approximately one-third of spinal cord injury patients report below-level neuropathic pain that is severe or excruciating. Patients may experience neuropathic pain associated with spinal cord injury as early as two weeks after injury and it may persist for up to 25 years.
"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 J. Romano, MD, senior vice president and head, medicines development group, Global Primary Care Business Unit, Pfizer. "The approval of Lyrica for this indication is a significant milestone, exemplifying Pfizer's commitment to pursue scientific advancements that address unmet medical needs."
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