Pfizer Inc. said the U.S. Food and Drug Administration approved Lyrica extended-release tablets to treat two nerve-related pain conditions: postherpetic neuralgia and neuropathic pain associated with diabetic peripheral neuropathy.
The approval does not cover the treatment of fibromyalgia, which is characterized by musculoskeletal pain.
The approval was based on the results of a placebo-controlled clinical trial involving 801 patients. In the drug arm of the study, 73.6% of the patients achieved at least 50% improvement in pain intensity compared with 54.6% in the placebo group.
The most common adverse reactions reported were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth and weight gain.