The primary endpoint was the log e-transformed 28 day seizure rate for all partial onset seizures collected during the double-blind treatment phase compared to the 8 week baseline (screening) seizure period.
The analysis of the primary endpoint, log e (28-days seizure rate + 1), showed a non-significant result between pregabalin and placebo for the pregabalin CR 330 mg group (p=0.0907). Responder rates, defined as the percentage of patients with a ≥ 50% reduction in seizure frequency from baseline, were 45.9%, 37.8% and 35.8% for the CR 330 mg, CR 165 mg, and placebo groups, respectively, and highlight the high placebo response observed in this study.
Both pregabalin CR 330 mg and pregabalin CR 165 mg were well tolerated in this population. The tolerability and safety findings are consistent with past pregabalin findings for patients with epilepsy, with dizziness, weight increased and somnolence as the most frequently reported adverse events in the study.
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).