The FDA has approved adding use in treatment of spinal cord injury to the indications for the neuropathic pain drug pregabalin (Lyrica).
The new indication makes pregabalin the first FDA-approved treatment for neuropathic pain from spinal cord injury, according to a statement from drug maker Pfizer.
The drug is already approved to treat diabetic nerve pain, pain after shingles, fibromyalgia, and partial-onset seizures in epileptic adults taking one or more seizure drugs.
Approval for the spinal injury indication was based on two randomized, double-blind, flexibly dosed, placebo-controlled phase III studies.
A combined 357 patients were given 150 to 600 mg pregabalin daily and were allowed to take other pain medications during the trial, including NSAIDs, opioids, and non-opioids. One trial involved traumatic spinal cord injury patients, while the other included a mix of traumatic and nontraumatic injury patients, such as those who had benign spinal tumor removal.
The trials found drug treatment significantly reduced neuropathic pain from the spinal cord injuries versus placebo through the respective 12 and 16 weeks of each study, and patients taking pregabalin had a 30% to 50% reduction in pain compared with those taking placebo.
Common adverse events in the trials were somnolence, dizziness, dry mouth, fatigue, and peripheral edema.
Other adverse events seen in post-market reports include angioedema, hypersensitivity, blurred vision, weight gain, constipation, euphoric mood, balance disorder, increased appetite, and abnormal thinking and attention.
Currently, there are more than 100,000 patients in the U.S. with neuropathic pain from spinal cord injuries, and about 12,000 new spinal cord injury patients are diagnosed annually, according to Pfizer.