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Carisbamate (YKP 509, proposed trade name Comfyde) is an experimental anticonvulsant drug under development by Johnson & Johnson Pharmaceutical Research and Development. In 1998, the compound was in-licensed from SK Corp. (currently Life Science Business Division of SK Holdings), a South Korean company. A phase II clinical trial in the treatment of partial seizures demonstrated that the compound has efficacy in the treatment of partial seizures and a good safety profile. Since late 2006, the compound has been undergoing a large multicenter phase III clinical trial for the treatment of partial seizures. Its mechanism of action is unknown.
On October 24, 2008, Johnson & Johnson announced that it had submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for carisbamate. Carisbamate has received provisional approval by the FDA to be marketed under the brand name of Comfyde. However, on August 21, 2009, Johnson & Johnson reported that the FDA had failed to give marketing approval.
A double-blind, placebo-controlled trial cf carisbamate in 323 patients with migraine failed to demonstrate that the active drug was more effective than placebo. However, carisbamate was well tolerated at doses up to 600 mg/day.
- Rogawski MA (2006). "Diverse mechanisms of antiepileptic drugs in the development pipeline". Epilepsy Res 69 (3): 273–294. PMC 1562526. PMID 16621450. doi:10.1016/j.eplepsyres.2006.02.004.
- Novak GP, Kelley M, Zannikos P, Klein B (2007). "Carisbamate (RWJ-333369)". Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics 4 (1): 106–109. PMID 17199023. doi:10.1016/j.nurt.2006.11.016.
- "Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate" (Press release). Johnson & Johnson. 2008-10-24. Retrieved 2008-11-02.
- Cady RK, Mathew N, Diener HC, Hu P, Haas M, Novak GP; Study Group. (2009). "Evaluation of carisbamate for the treatment of migraine in a randomized, double-blind trial". Headache 49 (2): 216–226. PMID 19222595. doi:10.1111/j.1526-4610.2008.01326.x.
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