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Carisbamate
Systematic (IUPAC) name
(S)-2-O-carbamoyl-1-o-chlorophenyl-ethanol
Identifiers
CAS number 194085-75-1
ATC code N03AX19
PubChem 6918474
Chemical data
Formula C 9H10ClNO3  
Mol. mass 215.633 g/mol
Pharmacokinetic data
Bioavailability  ?
Metabolism  ?
Half life  ?
Excretion  ?
Therapeutic considerations
Pregnancy cat.  ?
Legal status
Routes  ?

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 partical 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. 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. PMID 17199023.  
  3. ^ Johnson & Johnson (2008-10-24). "Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate". Press release. 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): 216-226. PMID 19222595.  







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