Avadel Pharmaceuticals PLC (NASDAQ: AVDL) shares jumped on Monday morning after the firm announced that the U.S. Food and Drug Administration (FDA) has agreed to the company’s proposed amendments to the statistical analysis plan and protocol under its special protocol assessment agreement. This is resulting in a lower sample size needed to demonstrate significance for both excessive daytime sleepiness and cataplexy in narcolepsy patients.
Note that no modifications were made to the fundamental design of the study, including the primary or secondary endpoints, dosing scheme or duration of the study, and the special protocol assessment agreement remains intact.
The Phase 3 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 the second quarter of 2020.
What makes this so significant is that this is up to a year ahead of expectations to complete enrollment for the previous target of 264 patients for the study. Even with this change, the Rest-On clinical trial remains one of the largest studies conducted to date for this indication.
Greg Divis, CEO of Avadel, commented:
This Rest-On clinical trial update is a direct result of an overall strategic review of the entire FT218 program. The addition of our recently appointed medical and clinical team members was instrumental in this important development and their contributions have put us on track to save significant time, resources and capital in the completion of the Rest-On clinical trial.
Shares of Avadel traded up 51.3% early Monday to $5.10, in a new 52-week range of $1.03 to $5.37. The consensus analyst price target was last seen at $4.50.