Jazz's JZP-258 reaches primary and secondary endpoints in Phase 3 trial to treat excessive drowsiness in the day
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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Today, Jazz Pharmaceuticals(http://announced that
it has reached its primary and critical secondary endpoints in theof the phase 3trial
(http://treating adult adult psychotic sleepiness () in the(http://JZP-258About JZP-258
JZP-258 is a new drug of hydroxybutylates, made up of unique cationsJZP-258 has a 92% reduction in sodium levels compared to Xyrem, another central nervous system inhibitor used by Jazz to treat onset sleepdisorders, improving the long-term safety of medication in patientsA total of 134 patientsparticipated in a phase 3 clinical trial in the randomized, double-blind, placebo-controlled group, where patients who had been treated with Xyrem alone, or Xyrem in combination with other anti-drowsiness drugsThe test included a dose optimization period of 12 weeks and a subsequent 2-week dose stabilization periodThe main endpoint was the number of weekly seizures in patients treated with JZP-258, as compared to the placebo group, and changes in the Epworth drowsiness scale score at the end of the 14th week trial The results showed that after the dose optimization period, the number of resonators per week in patients who continued to receive JZP-258 was consistent with the dose optimization period, while the number of reflux episodes per week increased significantly in patients treated with a placebo The median score of Epworth drowsiness scale score in patients who continued to receive JZP-258 during dose stabilization was significantly lower than in the placebo group Security: The JZP-258 shows security consistent with Xyrem
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