Carisbamate

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.

Carisbamate
Clinical data
Trade namesComfyde (proposed)
ATC code
Identifiers
CAS Number
PubChem CID
ChemSpider
UNII
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC9H10ClNO3
Molar mass215.63 g·mol−1
3D model (JSmol)
 NY (what is this?)  (verify)

Clinical study

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

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

  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. PMC 7479705. 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. S2CID 709835.
  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.
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.