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Label indication Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Xyrem is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ). FDA label
Also known as Xyrem®
JZP-258 · 2 trials · 2 indications
The ESS is a 8-item self reported questionnaire intended to measure daytime sleepiness. In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities. The ESS total score range is 1 to 24. Each activity is rated on a 4-point scale ranging from a minimum of "would never doze" to a maximum of "a high chance of dozing." Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome. A positive mean change value indicates an increase in score from the end of the stable dose period and worsened daytime sleepiness. A higher ESS score (above 10) reflects a greater average sleep propensity in daily life (ASP) , or daytime sleepiness.
Participants completed a daily Cataplexy Frequency Diary each night prior to bedtime. Participants were to record the number of cataplexy attacks that they had each day.
| Arm | Type | Description |
|---|---|---|
| JZP-258 | EXPERIMENTAL | JZP-258 at the stable dose and regimen for 2 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered at a volume and regimen equivalent to the JZP-258 dose and regimen for 2 weeks. |
| Name | Type | Description |
|---|---|---|
| JZP-258 | DRUG | Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period. |
| Placebo Oral Solution | DRUG | Participants randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period. |
| Placebo | OTHER | Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial \[United States Pharmacopeia/ National Formulary\]) |
Inclusion Criteria: 1. Male or female between 18 and 75 years of age, inclusive, at the time of consent. 2. Have a primary diagnosis of IH according to the International Classification of Sleep Disorders ICSD-2 or ICSD-3 criteria. 3. At the Screening Visit and the Baseline Visit, subjects who are n...
JZP-258 is an investigational small molecule being developed for the treatment of narcolepsy with cataplexy and idiopathic hypersomnia. It is in Phase 3 clinical development for both indications. The drug is not approved and remains under investigation in clinical trials.
JZP-258 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting Phase 3 clinical trials to evaluate the drug for narcolepsy with cataplexy and idiopathic hypersomnia.
JZP-258 is in Phase 3 clinical development. Two Phase 3 trials have been completed, one in narcolepsy with cataplexy and one in idiopathic hypersomnia. The drug is investigational and has not been approved by regulatory authorities.
JZP-258 has been studied in two completed Phase 3 trials. NCT03030599 evaluated the drug in 201 participants with narcolepsy with cataplexy. NCT03533114 evaluated the drug in 154 participants with idiopathic hypersomnia. Both trials were randomized, double-blind, and placebo-controlled.
JZP-258 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for narcolepsy with cataplexy and idiopathic hypersomnia. The completed Phase 3 trials will inform potential regulatory submissions, but approval status has not been granted.