1011 Individualized Dosing with Low-Sodium Oxybate in Idiopathic Hypersomnia: Patient Voices from LYRICAL

Abstract Introduction In the US, low-sodium oxybate (LXB; Xywav®) is approved by the Food and Drug Administration for the treatment of idiopathic hypersomnia (IH) in adults, and has the option for individualized dosing. The LYRICAL study examined the real-world treatment experience of US adults taking LXB, to provide greater insights into LXB dosing patterns from the perspective of adults with IH. Methods This longitudinal, mixed methods study collected quantitative and qualitative data from participants currently taking LXB for ≥12 weeks. An online survey (n=40) consisting of standardized patient-reported outcome measures and de novo questions was administered at enrollment, week 12, and week 24. Interviews were conducted in a subset of participants (n=13) at enrollment and week 24. Descriptive analyses assessed LXB use patterns, including LXB dosing regimens, any variability/changes since enrollment, and perceptions of individualized dosing. Results In 40 participants, mean age was 32.7 years (standard deviation SD=8.0), and most were female (72.5%) and White (62.5%). Mean LXB treatment time was 83.2 weeks (SD=65.9). Most participants (85.0%) reported taking LXB twice-nightly, typically as 4.5 g + 4.5 g (20.6%) or 4.0 g + 4.0 g (17.6%), with 9.0 g being the most common total nightly dosage. Asymmetric doses were reported by 11 survey participants (32.4%), typically with a lower second dose. Participants worked with their healthcare providers to tailor their dosing regimens, with staying asleep (n=5) and help falling asleep (n=3) as the most common reasons for asymmetric doses. Those who adjusted their LXB regimen during the study (n=9) were more likely to report improved convenience and effectiveness (Treatment Satisfaction Questionnaire for Medication version 9). Interview data (n=13) showed that shared decision-making with providers helped participants reach their current dosing regimens, with slower dose titration as the most common consideration for dose adjustment. At enrollment and week 24 of the interviews, 8/11 and 9/10 participants, respectively, reported that an individualized regimen was helpful for their lifestyle. Conclusion Real-world findings from LYRICAL underscore the importance of individualized LXB dosing and shared decision-making, which allowed participants to tailor regimens to optimize management and achieve high treatment satisfaction. Support (if any) Jazz Pharmaceuticals