Carisbamate Explained

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

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.

Notes and References

  1. Rogawski MA . Diverse mechanisms of antiepileptic drugs in the development pipeline . Epilepsy Res . 69 . 3 . 273–294 . 2006 . 16621450 . 10.1016/j.eplepsyres.2006.02.004 . 1562526.
  2. Novak GP, Kelley M, Zannikos P, Klein B . Carisbamate (RWJ-333369) . Neurotherapeutics . 4 . 1 . 106–109 . 2007 . 17199023 . 10.1016/j.nurt.2006.11.016. 7479705 . free .
  3. Cady RK, Mathew N, Diener HC, Hu P, Haas M, Novak GP, ((Study Group)) . Evaluation of carisbamate for the treatment of migraine in a randomized, double-blind trial. Headache. 2009 . 49. 216–226 . 19222595 . 2 . 10.1111/j.1526-4610.2008.01326.x. 709835.
  4. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate . Johnson & Johnson . 2008-10-24 . 2008-11-02.