Jazz Presents Results of Xywav (Oral Solution) in P-III Withdrawal Study for Adult Patients with Idiopathic Hypersomnia at AAN2021

April 21, 2021 Auto Bot Adult, Clinical Trials, Jazz, patients, Presents, results 0

Shots:

  • The P-III withdrawal study involves assessing the efficacy and safety of Xywav (oral solution) vs PBO in a ratio (1:1) in adult patients with idiopathic hypersomnia. The study includes a titration and optimization period of up to 14wks. followed by a 2wks. open-label, SDP
  • The study demonstrated a change in ESS score within 2wks., improvement in PGIc and IHSS. The safety profile was consistent with the known safety profile, and no new safety signals were observed
  • The additional data is submitted to the US FDA in the sNDA that was recently accepted for filing and granted Priority Review

Click here to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

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