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

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