A total of 441 subjects were enrolled into the SB phase from 49 sites in 4 countries (U.S., Canada, India, and Taiwan). Of the 441 subjects, 122 (28%) completed SB, had ≥50% pain response (i.e., ≥50% reduction in pain compared to baseline) and were randomized into DB. 122 subjects completed the single-blind phase and were randomized to the double-blind phase. One subject discontinued following randomization without receiving double-blind study medication, so 121 subjects received double-blind study medication and are included in the full analysis set.
The primary endpoint, defined as the time to loss of therapeutic pain response during DB (LTR; <30% pain response relative to the SB baseline mean pain or withdrawal due to lack of efficacy or adverse events), occurred in 34 of 63 (54.0%) patients in the pregabalin group as compared with 41 of 58 (70.7%) subjects in the placebo group. The median time from randomization to LTR was 58 days in the pregabalin group and 22 days in the placebo group. The difference between the treatments was statistically significant (log-rank p-value=0.021).
Pregabalin CR was well tolerated and the safety profile was consistent with the known profile for pregabalin (immediate release) in fibromyalgia patients. Adverse events reported in 5 percent or more of subjects included dizziness, somnolence, peripheral edema, insomnia, headache, fatigue, nausea, weight increased, vision blurred, dry mouth, and disturbance in attention.
About LyricaLyrica ® is currently approved for various indications in 120 countries and regions globally. Since its first approval from the FDA in 2004, Lyrica has been approved for five indications in the U.S., of which four are in the therapeutic area of pain. These indications include neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia (pain after shingles), neuropathic pain associated with spinal cord injury, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures. Antiepileptic drugs (AEDs) including Lyrica increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. There have been post-marketing reports of angioedema and hypersensitivity with Lyrica. Treatment with Lyrica may cause dizziness, somnolence, dry mouth, edema and blurred vision. Other most common adverse reactions include weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormal (primarily difficulty with concentration/attention).