Lyrica Approved for SCI Neuropathic Pain
People with spinal cord injury (SCI) now have a new drug to address neuropathic pain. In June, the FDA approved Lyrica (pregabalin) capsules.
“This milestone represents an important opportunity for physicians to more effectively manage the debilitating neuropathic pain that often accompanies spinal cord injury,” said Dr. Diana Cardenas, clinical study investigator; professor and chair of the Department of Rehabilitation Medicine at the University of Miami Miller School of Medicine; and chief of service for rehabilitation medicine and medical director of Jackson Rehabilitation Hospital. “Given the clinical challenges of investigating neuropathic pain in this patient population, any advancements in treatment are welcome by physicians and patients alike.”
According to the Northwest Regional Spinal Cord Injury System at the University of Washington School of Medicine, the most common type of chronic pain associated with SCI is neuropathic pain; it’s also the hardest to treat. Neuropathic pain can be experienced above, at or below the level of the spinal cord injury, and can occur in areas with no other sensation. This type of pain usually starts within a couple of weeks or months after injury.
The FDA approval of Lyrica is based on two randomized, double-blind, flexibly dosed (150–600 mg/day), placebo-controlled phase III trials, which enrolled 357 patients who had both traumatic and nontraumatic spinal cord injury. Patients were allowed to continue taking medications, including those for pain such as NSAIDs, opioids and non-opioids. The trials showed that Lyrica significantly reduced neuropathic pain associated with spinal cord injury from baseline throughout the duration of the studies, compared to placebo.
The most common adverse events associated with Lyrica use were drowsiness, dizziness, dry mouth, fatigue and swelling of lower limbs.