Avadel Pharmaceuticals (NASDAQ:AVDL) is up 31% premarket after FDA agrees with its proposed amendments to the statistical analysis plan for the REST-ON Phase 3 study for once-nightly sodium oxybate, FT218.
No modifications were made to the fundamental design of the study, including the primary or secondary endpoints, dosing scheme or duration of the study.
The REST-ON study will now target enrolling 205 patients. Based on this updated target sample size and enrollment currently at 193 patients, the company now expects to complete enrollment by the end of 2019 and have topline data in Q2 2020.
This is up to a year ahead of expectations to complete enrollment for the previous target of 264 patients for the study.
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