Pitolisant (Ozawade, 1) – Ozawade®

• Clinical trials
  • HAROSA I was a randomised, double-blind, placebo-controlled trial involving adults aged between 18 and 75 years who had been diagnosed with OSA.
  • The design of HAROSA II largely corresponds to that of the HAROSA I study; however, this study included patients (n = 268) who refused CPAP therapy and had an apnoea-hypopnoea index of ≥ 15/h.

Adults with excessive daytime sleepiness due to obstructive sleep apnoea (OSA), whose excessive daytime sleepiness could not be satisfactorily managed by primary OSA treatment, such as CPAP therapy, or where such treatment was not tolerated

• For adults with excessive daytime sleepiness due to obstructive sleep apnoea (OSA), whose excessive daytime sleepiness could not be satisfactorily managed by primary OSA therapy, such as CPAP therapy, or where such therapy was not tolerated, an additional benefit is not proven.
• Overall, there are no data available that are suitable for assessing the additional benefit.
• An additional benefit is therefore not proven.
• Morbidity – change in ESS score (Epworth Sleepiness Scale)
  • Endpoints recorded included, amongst others, the change in the ESS score, other morbidity endpoints and side effects.
• Overall assessment
  • Overall, there are no data available that are suitable for assessing the additional benefit. The additional benefit of pitolisant in the therapeutic indication of excessive daytime sleepiness due to obstructive sleep apnoea (OSA) in adults whose excessive daytime sleepiness could not be satisfactorily managed by primary OSA therapy, such as CPAP therapy, or where such therapy was not tolerated, it is not proven.

Courtesy translation only, please refer to the German original.