Abstract Details

Title Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm

Topic Sleep

Presentation(s) P10 - Poster Session 10 (11:45 AM-12:45 PM)

Poster/Presentation
Number 9-009

Objective

To calculate effect size (ES), number-needed-to-treat (NNT), and number-needed-to-harm (NNH), statistical representations of efficacy and tolerability that may assist clinicians’ treatment decisions, from two solriamfetol registrational studies in excessive daytime sleepiness (EDS) in adults with narcolepsy or obstructive sleep apnea (OSA).

Background Solriamfetol, a dopamine/norepinephrine reuptake inhibitor (DNRI) and TAAR1 activator, is approved to treat EDS in adults with narcolepsy or OSA.

Design/Methods Data (including published endpoints, post-hoc analyses, and AEs) from phase 3 trials in EDS associated with narcolepsy (TONES 2) or OSA (TONES 3) were used to calculate ES, NNT, and NNH.

Results On the maintenance of wakefulness test (MWT), ES versus placebo (Cohen’s d) were 0.29, 0.82, and 1.13 for 75mg, 150mg, and 300mg solriamfetol (TONES 2) and 0.46, 0.89, 1.08, and 1.28 for 37.5mg, 75mg, 150mg, and 300mg (TONES 3). On the Epworth sleepiness scale (ESS), Cohen’s d values were 0.47, 0.80, and 1.02 for 75mg, 150mg, and 300mg solriamfetol (TONES 2), and 0.42, 0.37, 0.99, and 1.04 for 37.5mg, 75mg, 150mg, and 300mg (TONES 3). NNT (patients with ESS ≤10) were 7, 5, and 3 for 75mg, 150mg, and 300mg (TONES 2) and 8, 6, 4, and 3 for 37.5mg, 75mg, 150mg, and 300mg (TONES 3). For patient global impression of change (PGIc) scores, NNT was 4, 3, and 3 for 75mg, 150mg, and 300mg solriamfetol (TONES 2) and 16, 5, 3, and 3 for 37.5, 75mg, 150mg, and 300mg (TONES 3). Clinician global impression of change (CGIc) NNT results were similar to those for PGIc. NNH pooled across doses for AEs (≥5% patients) in TONES 2 and TONES 3, were greater than placebo and <10%, except headache in TONES 2 (NNH=6).

Conclusions In this post-hoc analysis ES, NNT, and NNH were favorable for solriamfetol treatment of EDS associated with narcolepsy and OSA.

Authors/Disclosures
Samantha Floam, DMD (Axsome Therapeutics) PRESENTER	Dr. Floam has received personal compensation for serving as an employee of Axsome Therapeutics.
Craig Chepke (Excel Psychiatric Associates)	Craig Chepke has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Janssen. Craig Chepke has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Otsuka. Craig Chepke has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Craig Chepke has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Neurocrine. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AbbVie. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Acadia. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Otsuka. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Takeda. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Janssen. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Ironshore. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Craig Chepke has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion. Craig Chepke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Intracellular. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Eisai. Craig Chepke has received research support from Acadia. Craig Chepke has received research support from Harmony. Craig Chepke has received research support from Neurocrine.
Andrew Cutler	Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for AbbVie. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Alkermes. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Axsome. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Boehringer Ingelheim. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Bristol Myers Squibb. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Delpor. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for 4M Therapeutics. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Intra-Cellular Therapies. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for J&J. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Jazz Pharma. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Lundbeck. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for MapLight Therapeutics. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Neumora. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Neurocrine. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Noven. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Otsuka. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Relmada. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Supernus. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Teva. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Tris Pharma. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for COMPASS Pathways. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Freedom Biosciences. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for AbbVie. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Alkermes. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Axsome. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Intra-Cellular Therapies. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for J&J. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Lundbeck. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Neurocrine. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Noven. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Otsuka. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Supernus. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Teva. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Tris Pharma. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Vanda Pharmaceuticals. Andrew Cutler has stock in 4M Therapeutics. Andrew Cutler has stock in Relmada.
Gregory S. Parks, PhD (Axsome Therapeutics)	Dr. Parks has received personal compensation for serving as an employee of Axsome Therapeutics. Dr. Parks has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Parks has stock in Axsome Therapeutics. Dr. Parks has stock in Jazz Pharmaceuticals.
Russell Rosenberg (Neurotrials Research)	Mr. Rosenberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. The institution of Mr. Rosenberg has received research support from Neurotrials Research.

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