FDA Approves Lyrica for Neuropathic Pain from SCI

• By Laurie Watanabe
• Jul 17, 2012

The U.S. Food & Drug Administration (FDA) has approved Lyrica capsules to help manage the neuropathic pain commonly experienced by people with spinal cord injury (SCI).

Lyrica's manufacturer - Pfizer, Inc. - said in an announcement about the approval that about 40 percent of people with SCI suffer from chronic pain, and said it can be "severely debilitating and may significantly hinder rehabilitation and the ability to regain function."

The drug - also known by its generic name, pregabalin - was previously approved to treat neuropathic pain related to other conditions, such as diabetes and shingles. It's also used to treat fibromyalgia.

"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, M.D., senior VP 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."

Putting Lyrica to the Test

The FDA gave its approval after two randomized, double-blind Phase 3 trials of Lyrica. The 357 patients who participated were given either 150 to 600 mg of Lyrica per day, or placebos.

Patients in the first study had sustained traumatic SCI. The second study was primarily made up of traumatic SCI patients, but five percent of the group had sustained their SCI from non-traumatic causes, such as removal of spinal cord tumors.

Study participants continued to take other pain medications during the trials.

"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," Pfizer said in a news release. "In addition, more patients receiving Lyrica showed a 30-percent and 50-percent 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 commonly observed side effects, Pfizer added, were dizziness, dry mouth, fatigue, peripheral edema, and drowsiness.

Has SCI Pain Met Its Match?

Lyrica is meant to help manage patients' pain, not cure the actual cause of it. Nevertheless, having another weapon available for the pain-management fight could be very welcome news to people with SCI.

"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, M.D., MHA, professor and chair, department of rehabilitation medicine, University of Miami Miller School of Medicine. "Given the clinical challenges of investigating neuropathic pain in this patient population, any advancements in treatment are welcome by physicians and patients alike."