Pfizer has announced that the US Food and Drug Administration (FDA) approved the use of Lyrica (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury. Lyrica received a priority review designation for this new indication from the FDA.
“This milestone represents an important opportunity for physicians to more effectively manage the debilitating neuropathic pain that often accompanies spinal cord injury,” said clinical study investigator Diana Cardenas, professor and chair, department of rehabilitation medicine, University of Miami Miller School of Medicine and chief of service for rehabilitation medicine and medical director of Jackson Rehabilitation Hospital, Miami, Florida. “Given the clinical challenges of investigating neuropathic pain in this patient population, any advancements in treatment are welcome by physicians and patients alike.”
“Until now, no FDA approved treatment options were available in the USA for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling,” said Steven J Romano, 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.”
About Lyrica phase 3 clinical studies
The FDA approval is based on two randomised, double-blind, flexibly dosed (150–600 mg/day), placebo-controlled phase 3 trials, which enrolled 357 patients. Among other medications, patients were allowed to continue taking other pain medications, including NSAIDs, opioids and non-opioids. The population of one study consisted of traumatic spinal cord injury patients. The population of the other study consisted of traumatic spinal cord injury patients and patients who had injury to the spinal cord from non-traumatic causes: e.g., removal of a benign spinal tumor or spinal cord ischaemic stroke (5% of patients).
The primary finding in these studies was that Lyrica significantly reduced neuropathic pain associated with spinal cord injury from baseline throughout the duration of the studies (12 weeks and 16 weeks, respectively), compared to placebo. In addition, more patients receiving Lyrica showed a 30% and 50% reduction in pain than did patients receiving placebo. In some patients, the reduction in pain with Lyrica was significant as early as week one and continued throughout the duration of the trials.
The most common adverse events in these trials in patients receiving Lyrica were somnolence, dizziness, dry mouth, fatigue and peripheral edema.