Avadel Pharmaceuticals AVDL Stock News

Avadel Pharmaceuticals PLC (NASDAQ: AVDL) is making a run for the top in the market today, trading on gains of well over 35% early on. The company announced that the FDA has agreed to a reduction in sample size for a key clinical trial. Here’s what’s going on:

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AVDL Stock Climbs On FDA News

In a press release issued early this morning, Avadel Pharmaceuticals announced that the FDA has agreed to the company’s proposed amendments to the statistical analysis plan and protocal under its special protocol assessment agreement. As a result of the news, a lower sample size is needed to demonstrate significance for both excessive daytime sleepiness and cataplexy in narcolepsy patients.

In the release, AVDL said that no modifications were made to the fundamental design of the study. Importantly, primary and secondary endpoints, dosing scheme and the duration of the study will remain in tact.

Moving forward, the REST-ON study will target enrollment of 205 patients. The company said that enrollment currently stands at 193 patients. As a result of the change, the company now expects to complete enrollment by the end of 2019.

Moreover, the comapny said that it intends on topline data being available in the second quarter of next year.

In a statement, Greg Divis, CEO at AVDL, had the following to offer:

 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.

Why Investors Are So Excited

There’s a good reason Avdel Pharmaceuticals is running for the top in the market this morning. First and foremost, keep in mind that the REST-ON clinical trial is a Phase 3 trial that, if positive, will open the door to the submission of a New Drug Application.

Importantly, due to the reduction in required sample size, the trial will now be completed about a year ahead of expectations. Moreover, even with the change, the trial remains one of the largest studies conducted, to date, for this indication.

All in all, the news today shows that the company has taken a large step closer to the potential commercial availability of the drug, and increase the value of their work tremendously.

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