The US FDA granted approval for Jazz Pharmaceuticals PLC (NASDAQ:JAZZ)’s Xywav oral solution to treat excessive sleep during daytime or narcolepsy.
Jazz received the FDA nod for its Xywav after Phase 3 placebo-controlled and double-blind and multicenter clinical trials worldwide. The oral solution exhibited safety and efficacy in curing patients with chronic sleep or cataplexy.
The global clinical study involving Xywav is conducted on 201 patients. It scored high in mitigating the cataplexy attacks on a weekly scale compared to the placebo. Ingredients in Xywav oral solution are 92% less sodium compared to sodium oxybate, potassium, magnesium, calcium, and sodium oxybates. Several people suffering from chronic sleep (narcolepsy), along with cardiovascular disease and hypertension.
Xywav oral solution for people aged above 7 years
The Xywav oral solution is recommended for people aged over 7 years to treat chronic sleep or excessive sleep during the day. The recommended dose for night treatment is 1,000 to 1,500 mg compared to sodium oxybate (at 6 to 9 grams).
Pediatric patients and adults can choose multiple dosing options of Xywav to cure excessive or chronic sleep. The physicians can recommend unequal doses of Xywav for a night on diagnosing the patients’ sleep patterns.
The patients can consume Xywav after taking 6 to 9 grams of Sodium Oxybate. It can be titrated based on tolerability and efficacy. Jazz’s Xywav solution helps to reduce the dose of Sodium oxybate for the treatment of chronic sleep.
Many Americans consume excessive sodium daily. Excessive sodium intake daily causes a spike in blood pressure and results in stroke, hypertension, and other cardiovascular diseases.
Previously Sodium Oxybate is the only option to treat chronic sleep or excessive sleep during day time. The medicine carries a warning label for patients aged above 7 years to cure EDS and Cataplexy. Jazz developed Xywav oral solution to reduce sodium intake and provide opt treatment for cataplexy and EDS.
Launch of Xywav by the end of 2020
Jazz will introduce Xywav oral solution by implementing REMS (Risk Evaluation/ mitigation strategy) by the end of this year. It will ensure the supply of medicine to appropriate patients in a broad range.