Approval Probability
TA Base Rate
Adjusted LOA
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Also known as solriamfetol
JZP-110 · 7 trials · 4 indications
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.
Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from week 4 to week 6.
Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period.
Subjects were instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 kilometers (km) per hour (hr). Deviation was measured by the vehicle's speed and lateral distance to the left lane line and was continuously recorded. Individual improvement was defined as a decrease in SDLP below the negative value of threshold; individual impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
| Arm | Type | Description |
|---|---|---|
| 75 mg of JZP-110 | ACTIVE_COMPARATOR | Once Daily Dosing |
| 150 mg JZP-110 | ACTIVE_COMPARATOR | Once Daily Dosing |
| 300 mg of JZP-110 | ACTIVE_COMPARATOR | Once Daily Dosing |
| Placebo | PLACEBO_COMPARATOR | Once Daily Dosing |
| 37.5 mg of JZP-110 | ACTIVE_COMPARATOR | Once Daily Dosing |
| 150 mg of JZP-110 | ACTIVE_COMPARATOR | Once Daily Dosing |
| 75, 150, 300 mg of JZP-110 | ACTIVE_COMPARATOR | Once Daily Dosing |
| 75 mg - 300 mg of JZP-110 | OTHER | Once Daily Dosing |
| Arm A | EXPERIMENTAL | JZP-110 and Placebo |
| Arm B | EXPERIMENTAL | JZP-110 and Placebo |
| Arm C | PLACEBO_COMPARATOR | Placebo |
| JZP-110 | ACTIVE_COMPARATOR | 150 mg/day for first 3 days and 300 mg/day for next 4 days |
| Name | Type | Description |
|---|---|---|
| JZP-110 | DRUG | - |
| Placebo oral tablet | DRUG | - |
| Placebo | OTHER | - |
Major Inclusion Criteria: 1. Males and females between 18 and 75 years of age, inclusive 2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria 3. Body mass index from 18 to \<45 kg/m2 4. Consent to use a medically acceptable method of contraception 5. Willing and able to provide written ...
JZP-110 is an investigational small molecule being developed by Jazz Pharmaceuticals plc for excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and Parkinson's disease. It is in clinical development and has been studied in placebo-controlled, double-blind trials. It is not described as approved.
JZP-110 is being developed by Jazz Pharmaceuticals plc, which trades under the ticker JAZZ. The company has sponsored Phase 2 and Phase 3 clinical trials of the drug in excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and Parkinson's disease.
JZP-110 is in Phase 2 development, with completed Phase 2 trials in narcolepsy, obstructive sleep apnea, and Parkinson's disease. A completed Phase 3 long-term safety study in narcolepsy and obstructive sleep apnea has also been conducted. The drug is investigational and is not described as approved.
JZP-110 has been studied in completed trials including NCT03037203 in Parkinson's disease and excessive sleepiness, NCT02806908 in narcolepsy, NCT02806895 in obstructive sleep apnea, and the Phase 3 long-term safety study NCT02348632 in narcolepsy or obstructive sleep apnea. Total enrollment across these studies was 908 participants.
JZP-110 is being developed to treat excessive sleepiness in narcolepsy. Completed trials include a Phase 2 study assessing its effects on driving performance, NCT02806908, and the Phase 3 long-term safety study NCT02348632, which enrolled patients with narcolepsy or obstructive sleep apnea.
JZP-110 is being developed to treat excessive sleepiness in obstructive sleep apnea. Completed studies include a Phase 2 trial assessing driving performance, NCT02806895, and the Phase 3 long-term safety study NCT02348632, which enrolled 645 participants with narcolepsy or obstructive sleep apnea.