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.

“With fatigue, excessive daytime sleepiness is the symptom most frequently reported by patients, with a considerable impact on quality of life and on daily safety,” said Jean-Charles Schwartz, scientific director and co-founder of Bioprojet.

“Ozawade provides an effective solution to all patients, whether they are treated by PPC or intolerant of this treatment.”

“The HAROSA I and II studies in particular demonstrated that taking pitolisant had no impact on systolic or diastolic blood pressure and did not increase the risk of hypertension. In fact, the mode of action for Ozawade is distinct from that of psychostimulants which gives it a favourable safety profile, which is essential for a population which often has metabolic and cardiovascular co-morbidities,” he added.