A post-authorisation safety study (PASS) to evaluate cardiovascular events in adult patients with obstructive sleep apnoea (OSA) treated with solriamfetol (JZP865-401)

Study identification

• EU PAS number:
  EUPAS45651
• Study ID:
  50596
• Official title and acronym:
  A post-authorisation safety study (PASS) to evaluate cardiovascular events in adult patients with obstructive sleep apnoea (OSA) treated with solriamfetol (JZP865-401)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany
• Study description:
  Obstructive sleep apnoea (OSA) is a breathing condition when airways are narrowed due to muscle relaxation and can result in the airway obstruction and apnoea. Solriamfetol is indicated to reduce EDS in adult patients with narcolepsy or obstructive sleep apnea in whom EDS has not been satisfactorily treated by primary OSA therapy. Per EMA requirement, Jazz Pharmaceuticals/Axsome Therapeutics aims to carry out a PASS of solriamfetol in patients with OSA in Europe to assess the safety of the treatment and to evaluate MACE and other potential safety outcomes in adult patients. This study will be a prevalent new user cohort study using secondary data sources (claims/EHR) conducted in Germany and France, where solriamfetol has been marketed. The primary objective of this study is to estimate and compare the incidence rate of incident MACE, as a composite endpoint of: All cardiovascular (CV) mortality, non-fatal acute myocardial infarction, and non-fatal stroke, in adults newly exposed to solriamfetol plus positive airway pressure with patients exposed only to continuous PAP (C-PAP). The study population will be patients diagnosed with OSA at 18 years of age or greater and treated with C-PAP for at least one month with or without pharmacological intervention (solriamfetol or other wake-promoting agents). Main exposure will be solriamfetol and non-pharmacological intervention for airway obstruction (positive airway pressure). Secondary exposures will be the wake-promoting agents. The primary outcome will be a composite measure of MACE including All CV mortality, non-fatal acute MI, non-fatal stroke. Patients treated with solriamfetol plus C-PAP will be compared with patients exposed to C-PAP alone, adjusting for disease severity and known cardiovascular risk factors. Multivariable adjusted hazard ratio (HR) of MACE outcome will be measured comparing those exposed to solriamfetol (plus C-PAP) vs C-PAP only.
• Study status:
  Planned

Research institutions and networks

Institutions

IQVIA

United Kingdom

Multiple centres: 2 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 26/05/2022

Actual: 26/05/2022

Study start date

Planned: 01/02/2024

Data analysis start date

Planned: 22/02/2024

Date of interim report, if expected

Planned: 20/11/2024

Date of final study report

Planned: 31/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pharmanovia (Atnahs Pharma UK Ltd)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)