28th October 2021
The European Medicines Agency (EMA) has approved Bioprojet’s Ozawade (pitolisant) for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA) in adults.
Ozawade was evaluated in two Phase III clinical studies in the treatment of EDS in patients suffering from OSA – HAROSA I and HAROSA II.
The two studies showed a ‘significant improvement’ in the Epwoth Sleepiness Scale score (ESS) in patients treated with Ozawade, with no notable cardiovascular incidents or significant change in blood pressure/heart rate observed.
Following the EMA approval, Ozawade is indicated to improve wakefulness and reduce EDS in adult patients suffering from OSA, whose EDS has not been treated successfully by a primary treatment for the condition – including continuous positive pressure (CPP) – or for those who do not tolerate CPP.
In USA，Ozawade (pitolisant) sold as brand name Wakix.