Efficacy and Safety in People Transitioning to Lower-Sodium Oxybate: Data From the Transition Experience of Patients With Narcolepsy Taking Oxybate in the Real-World (TENOR) Study

Abstract: Introduction: The TENOR study examines the transition from sodium oxybate (SXB) to lower-sodium oxybate (LXB; 92% less sodium than SXB) in a real-world setting. Methods: TENOR is a patient-centric, prospective, observational, noninterventional, virtual-format study (NCT04803786). Eligible participants include US adults with narcolepsy (type 1 or 2) transitioning from SXB to LXB within the previous/upcoming 7 days (data collected for 21 weeks post-transition). Efficacy measures (Epworth Sleepiness Scale [ESS]; Functional Outcomes of Sleep Questionnaire, Short Version [FOSQ-10]; and British Columbia Cognitive Complaint Inventory [BC-CCI]) are collected at baseline (taking SXB) and weekly beginning week 1 (taking LXB). Participants were proactively queried about tolerability. These analyses include data through week 1 on LXB. Results: Analyses include 85 participants (type 1, n=45; type 2, n=40) at baseline and 79 participants at week 1. At baseline, mean (SD) age was 40.3 (13.0) years; most participants were female (73%), White (87%), and took ≥1 concomitant medication for narcolepsy with SXB (79%). Patient-reported comorbidities included depression (54%), anxiety (46%), obstructive sleep apnea (27%), and hypertension (24%). Baseline and week 1 mean (SD) ESS scores were 9.9 (5.2) and 9.7 (5.2), respectively; mean (SD) FOSQ-10 scores were 28.7 (7.1) and 28.8 (7.5), respectively; and mean (SD) BC-CCI scores were 6.1 (4.4) and 6.1 (4.7), respectively. LXB tolerability was consistent with the known safety profile of SXB. Conclusions: Efficacy of oxybate for the treatment of narcolepsy was maintained 1 week after switching to LXB. Longer-term maintenance of efficacy and safety will be reported at study completion.Short Description: This analysis describes efficacy and safety data from the Transition Experience of Patients With Narcolepsy Taking Oxybate in the Real-World (TENOR) study. The findings provide valuable insights regarding the efficacy and tolerability of oxybate treatment in real-world patients transitioning from sodium oxybate to lower-sodium oxybate. Efficacy was maintained 1 week post-transition in excessive daytime sleepiness (Epworth Sleepiness Scale), quality of life (Functional Outcomes of Sleep Questionnaire, Short Version), and cognition (British Columbia Cognitive Complaint Inventory).Name of Sponsoring Organization(s): Jazz Pharmaceuticals