FDA Approves Drug to Manage Spinal Cord Injury Pain

(NIH)

Pfizer Inc. in New York says the U.S. Food and Drug Administration (FDA) has approved its drug pregabalin, marketed as Lyrica, to manage neuropathic pain associated with spinal cord injury. The drug was given a priority review by FDA.

Spinal cord injuries can happen to young, healthy people as a result of trauma from car accidents, falls, sports injuries, industrial accidents, or gunshots. Older people can suffer spinal cord damage associated with the weakening of the spine from rheumatoid arthritis or osteoporosis. Non-traumatic causes of spinal cord injury can also include congenital and developmental abnormalities, genetics and metabolism, infections and inflammation, removal of a benign spinal tumor and spinal cord ischemic stroke.

The company says some 40 percent of patients with spinal cord injuries in the U.S. experience neuropathic pain. Researchers at University of Alabama-Birmingham say the pain is caused by damage to the nervous system resulting from the injury, often described as a sharp, shooting, or burning pain. Patients with spinal cord injury can begin feeling the pain weeks or months after the injury, often at or below the level of injury.

Pregabalin had already been approved for fibromyalgia, diabetic nerve pain, and pain after shingles, as well as to treat partial onset seizures in adults with epilepsy. FDA’s priority preview process is used for drugs that the agency feels offer major advances in treatment, or provide a treatment where no adequate therapy exists. The goal for completing a priority review is six months.

Pfizer says the FDA approval was based on on two randomized, double-blind, placebo-controlled phase 3 clinical trials involving 357 patients with spinal cord injuries from traumatic and non-traumatic causes. The trials allowed for flexible dosages of pregabalin, from 150 to 600 mg per day. The trials found pregabalin reduced neuropathic pain associated with spinal cord injury throughout the 12 to 16 weeks of the studies, compared to the placebo. More people taking the drug — by 30 and 50 percent respectively — experienced reductions in pain than did patients receiving the placebo.

Since pregabalin is an anti-epilepsy drug, Pfizer warns the drug increases the risk of suicidal thoughts or behavior. Other adverse reactions reported include angioedema (swelling similar to hives), hypersensitivity, dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, constipation, euphoric mood, balance disorder, increased appetite and difficulty with concentration or attention.

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