GlaxoSmithKline (NYSE: GSK – News) and Valeant Pharmaceuticals International, Inc. (NYSE: VRX – News) recently announced that their epilepsy drug, Potiga (ezogabine) gained US Food and Drug Administration (FDA) approval. The FDA granted approval for the use of Potiga as an adjunctive treatment of partial-onset seizures in patients aged 18 years and older.
Potiga will, however, be classified as a controlled substance under the Controlled Substances Act (CSA) and will not be available until the classification process is completed. Glaxo and Valeant expect to launch the drug by year end.
Moreover, Potiga will be available with a Risk Evaluation and Mitigation Strategy (REMS), which will make physicians aware of the risk of urinary retention and the symptoms of acute urinary retention. Potiga was seen to cause urinary retention in clinical trials.
Glaxo and Valeant had previously received a Complete Response Letter (CRL) from the FDA for Potiga in Nov 2010. The companies had responded to the CRL earlier this year.
Ezogabine is already approved in the EU under the trade name Trobalt. Glaxo and Valeant received marketing authorization for the use of Trobalt as an add-on treatment of partial onset seizures, with or without secondary generalization, in adults aged 18 years and above with epilepsy.
EU approval, which came in March 2011, was granted on the basis of data from two pivotal phase III studies, RESTORE 1 and 2, and one phase IIb study, Study 205. Results from these studies showed a 50% or more reduction in the frequency of seizures in patients being treated with Trobalt compared to patients on placebo.
From Yahoo.com
