JAZZ PHARMS — Xyrem FDA Review (NDA/BLA 021196, 2022)

JAZZ PHARMS · 2022 · FDA Review (Drugs@FDA) · company profile →

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The FDA approved Jazz Pharmaceuticals' Xyrem (sodium oxybate) on October 26, 2018, for treating cataplexy or excessive daytime sleepiness in pediatric narcolepsy patients aged 7 and older. This approval followed a Priority Review of the supplemental New Drug Application (sNDA). Clinical trials, particularly Study 13-005, demonstrated Xyrem's significant efficacy over placebo in reducing cataplexy attacks, with a safety profile comparable to adults. Due to Xyrem's CNS depressant effects and abuse potential, a comprehensive Risk Evaluation and Mitigation Strategy (REMS) program is in place, which was modified to include pediatric patient and caregiver considerations. The REMS outlines strict requirements for prescribers, pharmacies, and patients to ensure safe use and mitigate risks of misuse, abuse, and diversion.

Key findings — cited to the page

Proposed labeling communication date	October 4, 2018	· p.20
Side effect reporting contact (FDA)	1-800-FDA-1088	XYREM · p.117
Pediatric assessment requirement	Exempt	· p.22
Minimum age for use	7 years of age	XYREM · p.102
Contraindications	Alcohol and sedative hypnotics	XYREM · p.102
Controlled substance schedule	Schedule III	XYREM · p.102
REMS Program requirement	required	XYREM · p.104
Indication	treatment of cataplexy or excessive daytime sleepiness (EDS)	XYREM · p.102
Time to avoid hazardous activities after dosing	6 hours	XYREM · p.108
Disposal timeframe for unused prepared doses	24 hours	XYREM · p.116
Most common side effects	nausea, dizziness, throwing up, bedwetting, and diarrhea	XYREM · p.117
Healthcare provider check-up frequency after dose established	3 months	XYREM · p.119

Source: JAZZ PHARMS ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →