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 In pharmacology, the term mechanism of action (MOA) refers to the specific biochemical interaction through which a drug substance produces its pharmacological effect. A mechanism of action usually includes mention of the specific molecular targ ...

is unknown. 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.

History

In 1998, the compound was in-licensed from SK Corp. (currently Life Science Business Division of

SK Holdings SK Inc. () is a holding and IT services company headquartered in Seoul, South Korea. The company is divided into Investment Division and Business Division. The Investment Division operates as a holding company engaged in petroleum, telecommunica ...

), 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 The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA) for carisbamate. 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

{{GABAAR PAMs Anticonvulsants Carbamates Secondary alcohols Chloroarenes Johnson & Johnson brands GABAA receptor positive allosteric modulators Abandoned drugs