Sleepiness Treatment Under FDA Review

If approved, this formulation of sodium oxybate will be the first once-nightly oxybate treatment for daytime sleepiness.

The US Food and Drug Administration (FDA) has accepted Avadel Pharmaceuticals New Drug Application (NDA) for FT218 for review. FT218 is a formulation of sodium oxybate that uses Avadel’s MicroPump™ controlled-release (CR) technology for the treatment of severe daytime sleepiness and cataplexy in adults with narcolepsy.

“The FDA’s acceptance of our NDA for once-nightly FT218 and assignment of a PDUFA target action date of October 15th represents another important milestone on the path towards receiving approval. We are confident in our regulatory filing strategy and we look forward to working with the Agency in our pursuit of bringing this important treatment to patients,” Greg Divis, Chief Executive Officer of Avadel, said to the press. “If approved, FT218 will be the first and only once-nightly oxybate medication, a significant advancement to the twice-nightly regimen that has been required for nearly 20 years.”1

Avadel’s NDA submission is supported by positive data from the phase 3 REST-ON study, completed under a Special Protocol Assessment (SPA) agreement with the FDA. In the first half of 2021, Avadel intends to present data from the study for the 3 primary endpoints, a number of secondary endpoints, and post-hoc analyses at upcoming conferences.

“It’s important to remember that FT218 was granted Orphan Drug Designation by the FDA based on the plausible hypothesis that it may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the Agency for the same indication. If the FDA approves FT218 and grants Orphan Drug Exclusivity, then we would be awarded a seven-year period of market exclusivity in the US,” said Divis.1

The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021.

Additionally, 4 phase studies from the FT218 pharmacokinetic program will be published in the article, “Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults,” in Clinical Therapeutics.2

“These data should instill confidence in clinicians and patients regarding the robust phase 1 development program for FT218, with the demonstration of predictable blood levels of the active ingredient with a single dose, and a low residual amount of active drug remaining when a patient would awaken,” David Seiden, MD, lead author and senior medical director of clinical development and medical affairs at Avadel Pharmaceuticals, told the press. “As a sleep medicine physician and researcher, I am pleased that we have leveraged our proven technology to move toward the goal of patients potentially having access to a once-nightly sodium oxybate treatment.”2

References

1. Avadel Pharmaceuticals. Avadel Pharmaceuticals announces FDA acceptance of New Drug Application for FT218 in adults with narcolepsy for the treatment of excessive daytime sleepiness and cataplexy. News release. March 1, 2021. https://www.globenewswire.com/news-release/2021/03/01/2184208/0/en/Avadel-Pharmaceuticals-Announces-FDA-Acceptance-of-New-Drug-Application-for-FT218-in-Adults-with-Narcolepsy-for-the-Treatment-of-Excessive-Daytime-Sleepiness-and-Cataplexy.html

2. Avadel Pharmaceuticals. Avadel Pharmaceuticals announces publication of once-nightly FT218 pharmacokinetic studies. News release. March 2, 2021. https://investors.avadel.com/news-releases/news-release-details/avadel-pharmaceuticals-announces-publication-once-nightly-ft218