Avadel Pharmaceuticals plc is restructuring to assure funds required to focus on its FT218 clinical program, currently in Phase III development for the treatment of excessive daytime sleepiness (EDS) and Cataplexy in patients suffering from Narcolepsy. Avadel expects to reduce costs by $70 to $75 million in 2019 as a result of the restructuring plan, driven primarily by exiting Noctiva, a treatment for nocturia due to nocturnal polyuria in adults who awaken at least twice per night.

Sales of NOCTIVA since its launch have been highly disappointing despite a substantial investment of resources. Once fully implemented, the plan will lower the company’s cost structure by $80 to $90 million in 2020 and beyond when compared to 2018.

The company’s workforce will be downsized by more than 50% as part of the restructuring. Separately, Avadel Specialty Pharmaceuticals, LLC, a subsidiary, responsible solely for the sales, marketing and distribution of NOCTIVA, has made a voluntary filing under Chapter 11 of the United States Bankruptcy Code. 

“It is clear that FT218, an investigational, once-nightly formulation of sodium oxybate, is the Company’s most promising and commercially-attractive asset targeting a large orphan market with an estimated value of nearly $1.5 billion in 2018,” said Greg Divis, interim chief executive officer of Avadel. “If approved, we believe FT218, with once-nightly dosing, will provide a significant improvement for patients over the current standard-of-care. Our focus going forward is to direct our resources toward this development program. As part of our review of the Company’s operations, we have engaged third-party experts to evaluate the ongoing clinical development program of FT218, including the REST-ON Phase III trial, with the objectives of accelerating enrollment and assuring NDA filing readiness. To date, 149 patients have been randomized in the study, 56% of the overall enrollment goal.”