The Food and Drug Administration has approved the use of Lyrica for the management of neuropathic pain associated with chronic, debilitating spinal cord injuries. Lyrica, the brand name for pregabalin, is manufactured by Pfizer (NYSE: PFE) and is already widely used to treat fibromyalgia pain.
According to Pfizer, about 40 percent of the 270,000 Americans with spinal cord injuries suffer from chronic neuropathic pain that they describe as severe or excruciating. An estimated 12,000 new spinal cord injury patients are diagnosed in the U.S.each year.
Patients may experience neuropathic pain above, at or below the level of the spinal cord injury, and it may persist for up to 25 years. The pain stems from traumatic causes, such as motor vehicle accidents, violence, falls and sports injuries; where displaced bone fragments, disc material, or ligaments bruise or tear into spinal cord tissue.
Spinal neuropathic pain can also stem from non-traumatic causes, such as congenital and developmental abnormalities, genetics, infections and inflammation, removal of a benign spinal tumor and spinal cord ischemic stroke.
“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 of Pfizer’s global primary care unit.
The FDA’s approval was based on studies of 357 patients – some with traumatic spinal cord injuries, and some with both traumatic and non-traumatic injuries. In addition to Lyrica, patients in the randomized, double-blind, placebo controlled Phase III trials were allowed to continue taking other pain medications, including NSAIDS, opioids and non-opioids.
According to Pfizer, patients taking Lyrica received up to a 50% reduction in pain than did patients receiving a placebo. Some experienced relief as early as week one and continuing through the duration of the 12 and 16 week trials.
Side effects experienced by patients included somnolence, dizziness, dry mouth, fatigue and peripheral edema.
Pfizer recently halted studies testing Lyrica’s effectiveness in treating neuropathic pain caused by HIV infection or diabetes after preliminary results showed that it was no more effective than a placebo.