Jazz Pharmaceuticals announces SLEEP publication of phase III Xywav oral solution study in cataplexy or excessive daytime sleepiness in patients with narcolepsy.

Jazz Pharmaceuticals plc announced the publication of the global Phase III double-blind, placebo-controlled, randomized-withdrawal, multicenter study of Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution, for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. The results were published in SLEEP, the peer-reviewed, international journal of the Sleep Research Society. In the trial, Xywav achieved the primary and key secondary endpoints demonstrating highly statistically significant differences (p<0.0001) in median change in weekly number of cataplexy attacks and epworth sleepiness scale (ess) scores compared to placebo. results of the study were previously presented in an oral presentation at world sleep 2019. this phase iii study served as the basis of the fda approval of xywav for the treatment of cataplexy or eds in patients 7 years of age and older with narcolepsy. xywav is an oxybate product with a unique composition of cations resulting in 92 percent less sodium – or approximately 1,000 to 1,500 mg night less – than sodium oxybate at the recommended dosage range of 6 to 9 grams.2 meaningfully lowering the level of sodium ingested by patients taking oxybate therapy may help patients align with american heart association recommended levels of daily sodium intake. the study enrolled 201 participants and randomized 134 participants, which included those previously treated with sodium oxybate and naïve to sodium oxybate, with or without other anti cataplectic treatments. during the two week double-blind randomized withdrawal period, there was a significant increase in median weekly number of cataplexy attacks in participants randomized to take placebo compared with participants randomized to continue xywav treatment (median [q1, q3]: 2.35 [0.00, 11.61] vs 0.00 [?0.49, 1.75], respectively; treatment difference, p><0.0001). at the end of the double-blind randomized-withdrawal period, there was a significant increase in median ess scores in participants randomized to take placebo compared with participants randomized to continue xywav (median [q1, q3]: 2.0 [0.0, 5.0] vs 0.0 [?1.0, 1.0], respectively; treatment difference, p><0.0001). the most common adverse reactions reported by participants (?5%) were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety and vomiting. the company plans to launch xywav in the fourth quarter of this year, following risk evaluation and mitigation strategy (rems) implementation. see- "efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [lxb]; jzp-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy"- richard k bogan, michael j thorpy, yves dauvilliers, markku partinen, rafael del rio villegas ...sleep, zsaa206, https: doi.org 10.1093 sleep zsaa206 published: 14 october 2020.>