Carisbamate
Encyclopedia
Carisbamate is an experimental anticonvulsant
drug under development by Johnson & Johnson Pharmaceutical Research and Development
. In 1998, the compound was in-licensed from SK Corp. (currently Life Science Business Division of SK Holdings), a South Korean company. 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.
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. Carisbamate has received provisional approval by the FDA to be marketed under the brand name of Comfyde. However, on August 21, 2009, Johnson & Johnson reported that the FDA had failed to give marketing approval.
A double-blind, placebo-controlled trial cf carisbamate in 323 patients with migraine failed to demonstrate that the active drug was more effective than placebo. However, carisbamate was well tolerated at doses up to 600 mg/day.
Anticonvulsant
The anticonvulsants are a diverse group of pharmaceuticals used in the treatment of epileptic seizures. Anticonvulsants are also increasingly being used in the treatment of bipolar disorder, since many seem to act as mood stabilizers, and in the treatment of neuropathic pain. The goal of an...
drug under development by Johnson & Johnson Pharmaceutical Research and Development
Johnson & Johnson Pharmaceutical Research and Development
Johnson & Johnson Pharmaceutical Research and Development is a subsidiary of Johnson & Johnson that is responsible for discovering and developing pharmaceutical drugs...
. In 1998, the compound was in-licensed from SK Corp. (currently Life Science Business Division of SK Holdings), a South Korean company. 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
Mechanism of action
In pharmacology, the term mechanism of action refers to the specific biochemical interaction through which a drug substance produces its pharmacological effect...
is unknown.
On October 24, 2008, Johnson & Johnson
Johnson & Johnson
Johnson & Johnson is an American multinational pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. Its common stock is a component of the Dow Jones Industrial Average and the company is listed among the Fortune 500....
announced that it had submitted a New Drug Application
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
to the U.S. Food and Drug Administration (FDA) for carisbamate. Carisbamate has received provisional approval by the FDA to be marketed under the brand name of Comfyde. However, on August 21, 2009, Johnson & Johnson reported that the FDA had failed to give marketing approval.
A double-blind, placebo-controlled trial cf carisbamate in 323 patients with migraine failed to demonstrate that the active drug was more effective than placebo. However, carisbamate was well tolerated at doses up to 600 mg/day.