Abstract Details

Title Efficacy and Safety of Low-Sodium Oxybate in Narcolepsy Patients With/Without Psychiatric/Neurologic Comorbidities

Topic General Neurology

Presentation(s) P12 - Poster Session 12 (11:45 AM-12:45 PM)

Poster/Presentation
Number 2-004

Objective This post hoc analysis of a phase 3 trial (NCT03030599) assessed low-sodium oxybate (LXB; Xywav^®) efficacy and safety in narcolepsy participants with or without psychiatric/neurologic comorbidities.

Background Prior studies report high incidences of psychiatric/neurologic comorbidities in narcolepsy patients. LXB is an FDA-approved treatment for cataplexy or excessive daytime sleepiness in patients ≥7 years old with narcolepsy and for adults with idiopathic hypersomnia.

Design/Methods Adults (18-70 years) with narcolepsy with cataplexy optimized/titrated their LXB dose (≤12 weeks) before a 2-week stable-dose period. During a 2-week double-blind randomized-withdrawal period, participants switched to placebo or continued LXB. Epworth Sleepiness Scale (ESS) scores, average weekly number of cataplexy attacks, Patient Global Impression of Change (PGIc) scores, Patient Health Questionnaire-9 (PHQ-9) scores, and treatment-emergent adverse events (TEAEs) were evaluated in participants with or without psychiatric/neurologic comorbidities.

Results Of 201 participants, 84 reported baseline comorbidities (most commonly depression, migraine headaches, anxiety, and headache [non-migraine]). Imbalances between subgroups were observed regarding sex, race, ethnicity, and BMI. Compared with participants continuing LXB, participants randomized to placebo in both subgroups showed worsening (increases) in ESS scores (least squares mean differences, LXB vs placebo [95% CI], with comorbidities: −3.7 [−5.6, −1.9], P=0.0001; without comorbidities: −2.0 [−3.5, −0.6]; P=0.0050). Participants randomized to placebo in both subgroups had increased weekly cataplexy attacks (location shift, LXB vs placebo [95% CI], with comorbidities: −4.0 [−7.0, −1.1], P=0.0026; without comorbidities: −3.5 [−9.1, −1.1], P<0.0001). Participants randomized to placebo in both subgroups showed worsening in PGIc scores (P<0.0001, for both). PHQ-9 scores, indicating depressive symptoms, remained stable in both subgroups. TEAEs and serious TEAEs occurred in 69 (82.1%) and 1 (1.2%) participants with comorbidities, and 84 (71.8%) and 3 (2.6%) without comorbidities, respectively.

Conclusions The efficacy and safety of LXB in narcolepsy participants with psychiatric/neurologic comorbidities were similar to those in participants without psychiatric/neurologic comorbidities.

Authors/Disclosures
Thomas Measey PRESENTER	Thomas Measey has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Thomas Measey has stock in Jazz Pharmaceuticals.
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.
Nathaniel F. Watson, MD (University of Washington)	Dr. Watson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz Pharmaceuticals. Dr. Watson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for React Health. Dr. Watson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Harmony Biosciences.
Shawn A. Candler, MD (Dr. S. A. Candler)	Dr. Candler has received research support from Jazz Pharmaceuticals .
Douglas S. Fuller (Jazz Pharmaceuticals)	Mr. Fuller has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Mr. Fuller has stock in Jazz Pharmaceuticals.
Brian Scheckner	Brian Scheckner has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Brian Scheckner has stock in Jazz Pharmaceuticals.
Sarah Akerman, MD	Dr. Akerman has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Akerman has stock in Jazz Pharmaceuticals.
Nika Bejou, PharmD	Dr. Bejou has received personal compensation for serving as an employee of Jazz Pharmaceuticals.

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