Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for the treatment of excessive sleepiness in obstructive sleep apnea and narcolepsy. It is in clinical development for these neurology indications, with completed trials in both conditions.
JZP-110 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with excessive sleepiness.
JZP-110 is in Phase 2 clinical development. While some completed trials were Phase 3, the overall development program includes Phase 2 studies. The drug is investigational and has not been approved by regulatory authorities for any indication.
JZP-110 has completed several clinical trials, including NCT02348606 and NCT02348619 for obstructive sleep apnea, and NCT02806895 and NCT02806908 for driving performance in excessive sleepiness. These trials were conducted in the United States, Canada, and European countries.
JZP-110 is also known by the name solriamfetol. The drug has been studied under both names in clinical trials for excessive sleepiness associated with obstructive sleep apnea and narcolepsy.