FDA has approved Cephalon’s Risk Evaluation and Mitigation Strategy (REMS) for its epilepsy medication, Gabitril® (tiagabine hydrochloride). It comprises a medication guide to inform patients about the potential risks. The drug is indicated as an adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
The implementation of the REMS is a result of FDA's identification in 2008 of an increased risk of suicidal thoughts and behavior with antiepileptic drugs (AEDs). The current product labeling already contains a warning about risks, but the addition of a medication guide is expected to bolster awareness of risks.
The Gabitril medication guide will be available on the product website and will be dispensed with every prescription. The three-pronged REMS assessment plan will be implemented on an ongoing basis to evaluate patients' understanding of the potential serious risks associated with the medication, the distribution and dispensing of the medication guide, and adherence to distribution and dispensing requirements as well as corrective actions taken to address noncompliance.
For the first two quarters of this year, Cephalon reported selling over $21.9 million worth of Gabitril compared to approximately $28.03 million during the same period last year, marking an almost 22% drop. Specifically, the drug achieved sales of roughly $19.42 million in the U.S. and $2.49 million in Europe during the first six months of 2010. Total sales for 2009 was about $56.49 million compared to approximately $60.7 million in 2008.