0620 A Long-Term Safety and Maintenance of Efficacy Study of Solriamfetol (JZP-110) in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea
Bibliographic record
Abstract
Excessive sleepiness (ES) is a prominent symptom of narcolepsy and obstructive sleep apnea (OSA). Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, was effective in the treatment of ES in narcolepsy and in OSA in 6-week and 12-week phase 3 studies. This study evaluated the long-term safety and maintenance of efficacy of solriamfetol. Subjects with narcolepsy or OSA who had completed prior studies with solriamfetol were eligible. Subjects began treatment with solriamfetol in the 2-week Titration phase followed by a Maintenance phase up to 50 weeks. A 2-week placebo-controlled Randomized Withdrawal (RW) was conducted after 6 months of treatment. Change from beginning to end of the RW in Epworth Sleepiness Scale (ESS) was the primary endpoint; Patient and Clinician Global Impression of Change (PGI-C and CGI-C, respectively) were secondary endpoints. At the interim analysis, which included ongoing open-label and complete RW data, 638 subjects (226 narcolepsy; 412 OSA) had taken solriamfetol. Of these, 280 subjects (141 receiving placebo and 139 receiving solriamfetol) completed the RW (modified intent-to-treat population). At the end of the RW, ESS score increased by 1.6 (least squares [LS] mean) for the solriamfetol group compared with an increase of 5.3 (LS mean) for the placebo group (P<0.0001). For both secondary endpoints, a greater percentage of subjects in the placebo group was reported as worse at the end of the RW compared with the solriamfetol group (both P<0.0001). Long-term maintenance of efficacy was also demonstrated during the open-label period up to 1 year by sustained reductions in mean ESS scores and improvements in PGI-C and CGI-C. The most frequent treatment-emergent adverse events (AEs; ≥5%) with solriamfetol were headache, nausea, insomnia, nasopharyngitis, dry mouth, and anxiety; 19 (2.9%) subjects experienced one or more serious AEs. These results demonstrate long-term maintenance of efficacy with solriamfetol in the treatment of ES in subjects with narcolepsy or OSA. The safety profile was consistent with prior placebo-controlled studies of solriamfetol. Jazz Pharmaceuticals.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".