The U.S. Food & Drug Administration (FDA) announced the approval of several generic versions of Lyrica (pregabalin). Lyrica is approved for the treatment of several conditions, including, according to a press release, “neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.”
“Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.”
The companies that received approvals are Alembic Pharmaceuticals; Alkem Laboratories; Amneal Pharmaceuticals; Dr. Reddy’s Laboratories; InvaGen Pharmaceuticals; MSN Laboratories Ltd.; Rising Pharmaceuticals, Inc.; Sciegen Pharmaceuticals Inc.; and Teva Pharmaceuticals.
Lyrica is manufactured and sold by Pfizer.
Pregabalin Trials for Fibromyalgia
Two studies were conducted to evaluate the use of pregabalin in fibromyalgia patients. The first was a 14-week, double-blind, placebo-controlled, multicenter study. Daily Lyrica doses of 300 mg, 450 mg, and 600 mg were compared to placebo. There were no significant differences in pain scores between patients taking 600 mg compared to 450 mg of Lyrica, but adverse reactions differed based on dose. Pain reduction was observed as early as the first week. Any improvement in pain was reported in 47.6% of placebo patients (95% confidence interval [CI] 40.0–55.2%), 68.1% of 300 mg patients (95% CI 60.9–75.3%), 77.8% of 450 mg patients (95% CI 71.5–84%), and 66.1% of 600 mg patients (95% CI 59.1–73.1%).
The second trial was a six-month randomized withdrawal study. The study began with a six-week open-label dose optimization phase that with daily doses of 300 mg, 450 mg, and 600 mg. Responders were defined as patients who had at least a 50% reduction in Visual Analog Scale (VAS) pain score and rated their overall PGIC improvement as “much improved” or “very much improved.” During phase one 54% of patients achieved a tolerable pregabalin dose. Responders moved on to the double-blind treatment phase of the study either with the same dose they responded to in part one or placebo for six months. The primary outcome was time to loss of therapeutic response, which was defined as either less than a 30% reduction in VAS score from baseline during two consecutive visits during the double-blind phase, or worse disease symptoms warranting a new treatment strategy. During phase two, 38% of pregabalin patients and 19% of placebo patients completed 26 weeks of treatment.
According to the study, “When considering return of pain or withdrawal due to adverse events as loss of response (LTR), treatment with LYRICA resulted in a longer time to loss of therapeutic response than treatment with placebo. Fifty-three percent of the pregabalin-treated subjects compared to 33% of placebo patients remained on study drug and maintained a therapeutic response to Week 26 of the study. Treatment with LYRICA also resulted in a longer time to loss of response based on the [Fibromyalgia Impact Questionnaire], and longer time to loss of overall assessment of patient status, as measured by the [patient global assessment].”