Pfizer's Epilepsy Drug Lyrica Succeeds In Pediatric Study
Zacks Investment Research | May 18, 2018 03:21AM ET
Pfizer Inc. (NYSE:PFE) announced that a phase III study evaluating its epilepsy drugLyrica (pregabalin) in pediatric patients met the primary endpoint. The study was evaluating the use of Lyrica Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age, an indication for which Lyrica is not yet approved.
Top-line results from the study showed that adjunctive treatment with Lyrica 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo which was the primary efficacy endpoint. However, treatment with Lyrica at lower dose of 7 mg did not result in statistically significant reduction in seizure frequency versus placebo.
These data along with the data from previous studies will be submitted to the FDA for Lyrica pediatric exclusivity determination.
Lyrica has already lost patent exclusivity in Europe, Russia, Turkey, Israel and Central Asia. In the United States, a favorable court decision in July 2012 regarding generic challenges should protect Lyrica from genericization through Dec 30, 2018.
Meanwhile, Pfizer is pursuing a six-month patent-term extension from the FDA for pediatric exclusivity, which, if granted, will keep generic competition at bay till June 2019. We believe that the positive data from the pediatric study may ease Pfizer’s effort to get pediatric exclusivity.
Other than epilepsy, Lyrica is indicated to treat post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury in the United States. Lyrica is also indicated to treat partial onset seizures in patients four years of age and older. Sales of Lyrica declined 1% to $1.13 billion in the first quarter of 2018.
Shares of Pfizer have lost 1.5% year to date compared with industry ’s decline of 3.8%.
Zacks Rank & Stocks to Consider
Pfizer has a Zacks Rank #3 (Hold)
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