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Abstract Details

Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm
Sleep
P10 - Poster Session 10 (11:45 AM-12:45 PM)
9-009
Solriamfetol, a dopamine/norepinephrine reuptake inhibitor (DNRI) and TAAR1 activator, is approved to treat EDS in adults with narcolepsy or OSA. 

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). 

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.
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).
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 No disclosure on file
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.