The US Food and Drug Administration (FDA) has approved Pfizer's Lyrica (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury based on priority review.
The FDA approval is based on two randomized trials which showed 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.
Lyrica had previously been approved to treat fibromyalgia, diabetic nerve pain, post herpetic neuralgia, or pain following a case of shingles, and seizures in adults with epilepsy.
Pfizer global primary care business unit, medicines development group, senior vice president and head Steven Romano said until now, no FDA approved treatment options were available in the US for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling.
"The approval of Lyrica for this indication is a significant milestone, exemplifying Pfizer's commitment to pursue scientific advancements that address unmet medical needs," Romano added.
Neuropathic pain associated with spinal cord injury can be severely debilitating and may significantly hinder rehabilitation and the ability to regain function.
