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P005 Long-term safety and efficacy of solriamfetol for excessive daytime sleepiness: an open-label extension randomised withdrawal trial
  1. Colin M Shapiro1,
  2. Geert Mayer2,3,
  3. Jean-Louis Pepin4,
  4. Richard Schwab5,
  5. Jan Hedner6,
  6. Mansor Ahmed7,
  7. Nancy Foldvary-Schaefer8,
  8. Patrick J Strollo9,
  9. Kathleen Sarmiento10,
  10. Michelle Baladi11,
  11. Patricia Chandler11,
  12. Lawrence Lee11 and
  13. Atul Malhotra12
  1. 1University of Toronto, Toronto, Canada
  2. 2Hephata Klinik, Schwalmstadt, Germany
  3. 3Philipps University Marburg, Marburg, Germany
  4. 4Grenoble Alpes University Hospital, Grenoble, France
  5. 5University of Pennsylvania, Philadelphia, USA
  6. 6Sahlgrenska University Hospital, Gothenburg University, Gothenburg, Sweden
  7. 7Cleveland Sleep Research Center, Middleburg Heights, USA
  8. 8Cleveland Clinic Lerner College of Medicine, Cleveland, USA
  9. 9University of Pittsburgh/Veterans Administration Pittsburgh Health System, Pittsburgh, USA
  10. 10San Francisco Veterans Administration Healthcare System, San Francisco, USA
  11. 11Jazz Pharmaceuticals, Palo Alto, USA
  12. 12Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, La Jolla, USA


Introduction Solriamfetol (formerly JZP-110), a dopamine and norepinephrine reuptake inhibitor, has been approved in the United States to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy (75–150 mg) or obstructive sleep apnoea (OSA; 37.5–150 mg). A Marketing Authorisation Application for these indications is under review with the European Medicines Agency. This study evaluated the long-term safety and efficacy of solriamfetol.

Methods Participants with EDS associated with narcolepsy or OSA who completed prior solriamfetol studies initiated open-label treatment with a 2-week titration phase followed by a maintenance phase of ≤50 weeks. A 2-week, placebo-controlled, randomised withdrawal (RW) phase was conducted after 6 months. Change from beginning to end of the RW phase in Epworth Sleepiness Scale (ESS) was the primary endpoint; Patient and Clinician Global Impression of Change (PGI-C and CGI-C, respectively) were secondary endpoints.

Results Safety population comprised 643 participants (226 narcolepsy; 417 OSA); 280 participants (141 placebo; 139 solriamfetol) comprised the RW modified intent-to-treat population. A total of 458 participants (71%) completed the study. Maintenance of efficacy in this 1-year study was demonstrated on the ESS, PGI-C, and CGI-C. Least squares mean change from the beginning to the end of the RW phase in ESS score was 5.3 versus 1.6 in participants randomised to placebo or solriamfetol, respectively (P<0.0001). Greater percentages of participants randomised to placebo versus solriamfetol in the RW phase reported as worse on PGI-C and CGI-C (both P<0.0001). The most frequent adverse events (AEs; ≥5%) were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4.2%) participants had ≥1 serious AE.

Discussion These results demonstrate the long-term efficacy of solriamfetol for EDS in participants with narcolepsy or OSA. Safety profile following long-term administration was consistent with prior solriamfetol studies.

Support Jazz Pharmaceuticals.

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