Carisbamate

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Carisbamate
Carisbamate2DACS.svg
Clinical data
Trade namesComfyde (proposed)
ATC code
Identifiers
CAS Number
PubChem CID
ChemSpider
UNII
ChEMBL
Chemical and physical data
FormulaC9H10ClNO3
Molar mass215.633 g/mol
3D model (JSmol)
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Carisbamate (YKP 509, proposed trade name Comfyde) is an experimental anticonvulsant drug that was under development by Johnson & Johnson Pharmaceutical Research and Development but never marketed.

Clinical study[edit]

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]

A double-blind, placebo-controlled trial of carisbamate in 323 patients with migraine determined that carisbamate was well tolerated at doses up to 600 mg/day, but it failed to demonstrate that the drug was sufficiently more effective than placebo in migraine prophylaxis.[3]

History[edit]

In 1998, the compound was in-licensed from SK Corp. (currently Life Science Business Division of SK Holdings), a South Korean company. 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.[4] Johnson & Johnson received provisional approval by the FDA to market carisbamate under the brand name of Comfyde. However, on August 21, 2009, Johnson & Johnson reported that the FDA had failed to give marketing approval.

References[edit]

  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. PMID 16621450.
  2. ^ Novak GP, Kelley M, Zannikos P, Klein B (2007). "Carisbamate (RWJ-333369)". Neurotherapeutics. 4 (1): 106–109. doi:10.1016/j.nurt.2006.11.016. PMID 17199023.
  3. ^ 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. doi:10.1111/j.1526-4610.2008.01326.x. PMID 19222595.
  4. ^ "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.