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.
^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.
PMID19222595.
S2CID709835.