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 Lyrica Lyrica ® 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).
For Lyrica prescribing information in the United States, please visit www.lyrica.com.Pfizer Inc.: Working together for a healthier world ® At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com. DISCLOSURE NOTICE: The information contained in this release is as of November 16, 2012. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about a potential additional indication for Lyrica as a once-a-day treatment, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any supplemental drug applications that may be filed for such additional indication as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.