A0081275 was a multicenter, double-blind, randomized, placebo-controlled, two-way cross-over study of Lyrica in the treatment of fibromyalgia pain. A total of 197 patients diagnosed with both fibromyalgia and comorbid depression who were taking a stable dose of a single antidepressant medicine (either a selective serotonin reuptake inhibitor or a serotonin–norepinephrine reuptake inhibitor) for their depression for at least three months prior to the study were enrolled. In each of the two double-blind treatment periods, patients were randomized to receive Lyrica 300mg or 450mg or placebo twice daily during a 6-week treatment phase, followed by a 2-week washout period, and then crossed over to the opposite treatment for an additional 6 weeks.
The study met its primary endpoint, showing a statistically significant greater reduction in fibromyalgia pain in patients receiving Lyrica compared to patients receiving placebo assessed by diary-based, daily pain scores.
A0081269 was a multicenter, double-blind, randomized, placebo-controlled cross-over efficacy and safety study in patients with painful DPN who also had pain on walking. The co-primary endpoints were diabetic peripheral neuropathy pain assessed by diary-based, daily pain scores and pain on walking assessed after walking 50 feet on a flat surface. The study enrolled 205 patients who were randomized to receive Lyrica 150mg or 300mg daily or placebo during a 6-week double-blind phase, followed by a 2-week washout period, and then crossed over to the opposite treatment for an additional 6 weeks.
Painful diabetic peripheral neuropathy and pain on walking were reduced in patients treated with Lyrica or placebo. The study did not show a statistically significant difference between Lyrica and placebo in the co-primary endpoints.
Lyrica is already approved for neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, neuropathic pain associated with spinal cord injury, fibromyalgia, and partial onset seizures in adults with epilepsy who take one or more drugs for seizures.
For more information call (800) 438-1985 or visit Lyrica.com.