Difference between revisions of "Carisbamate"

Latest revision as of 10:21, 20 September 2010

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.^[1][2]

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.^[3] 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.^[4] However, carisbamate was well tolerated at doses up to 600 mg/day.

References

1. ↑ Rogawski MA (2006). "Diverse mechanisms of antiepileptic drugs in the development pipeline". Epilepsy Res. 69 (3): 273–294. doi:10.1016/j.eplepsyres.2006.02.004. PMC 1562526 Freely accessible. PMID 16621450. 
2. ↑ 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. doi:10.1016/j.nurt.2006.11.016. PMID 17199023. CS1 maint: Multiple names: authors list (link)
3. ↑ "Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate" (Press release). Johnson & Johnson. 2008-10-24. http://www.drugs.com/nda/comfyde_081024.html. Retrieved 2008-11-02. 
4. ↑ 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) (2): 216–226. doi:10.1111/j.1526-4610.2008.01326.x. PMID 19222595. CS1 maint: Multiple names: authors list (link)