Solriamfetol (2) – Sunosi®

• Clinical trials
  • The pharmaceutical manufacturer has submitted study 14-003. This is a randomised, double-blind, placebo-controlled study involving adults aged between 18 and 75 who had been diagnosed with OSA.
  • The pharmaceutical manufacturer also submits data from a patient population of study 14-005 in support of its application. This is an open-label, non-randomised extension study in which patients with OSA or narcolepsy who had previously completed a study by the pharmaceutical company involving solriamfetol (including study 14-003) were eligible to participate.

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

• 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, additional benefit is not proven.
• For the reasons stated, in particular the short study duration and the lack of individualised dosing, study 14-003 cannot be used to assess additional benefit. Consequently, no evaluation at the endpoint level is carried out.
• The supplementary single-arm study 14-005 cannot be taken into account, as the absence of a comparator arm means that no conclusions can be drawn regarding the additional benefit of solriamfetol compared with the appropriate comparator therapy.
• Overall assessment
  • Overall, there are no data available that are suitable for assessing additional benefit. The additional benefit of solriamfetol 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, is not proven.

Courtesy translation only, please refer to the German original.