The EMEA has published a questions and answers document explaining the reasons behind the withdrawal of the application for a marketing authorisation for lisuride (Nenad™), for the treatment of the signs and symptoms of moderate-to-severe idiopathic restless legs syndrome in adults.
The withdrawal was based on the Committee for Medicinal Products for Human Use (CHMP) opinion that the benefits of lisuride in the treatment of restless legs syndrome did not outweigh its risks.