Avadel Pharmaceuticals plc, a company focused on developing FT218 for sleep disorders, has appointed Jordan Dubow, MD, as chief medical officer. Dubow brings experience leading clinical development programs in sleep and neurological disorders to Avadel, where he will lead the development of FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients who have narcolepsy.

“Dr Dubow’s experience in a wide range of neurological disorders, especially sleep, will be invaluable to Avadel as we continue advancing FT218 toward approval and commercialization,” says Geoff Glass, chairman of Avadel Pharmaceuticals, in a release. “His appointment is a critical step as we pivot the company’s focus to assuring FT218 has the best possible chance of being the first approved once-nightly option for narcolepsy patients.”

Greg Divis, interim CEO of Avadel Pharmaceuticals, says, “Jordan will help us refine our clinical development and regulatory plans based on the review of our REST-ON program that we initiated in the first quarter with the objective of preparing a solid clinical data package to gain FDA approval and differentiated market positioning to drive FT218’s future commercial success.”

Dubow has both depth and breadth of experience in managing clinical development, medical affairs, business development and regulatory affairs, including multiple successful NDA submissions to the US Food and Drug Administration, across a wide range of neurological diseases including sleep disorders such as narcolepsy. Prior to joining Avadel, Dubow served as vice president, CNS therapeutic strategy with Esteve, a pharmaceutical company headquartered in Barcelona, Spain, where he was responsible for evaluating in-licensing candidates and provided regulatory and clinical support for the company’s entire development pipeline. Prior to Esteve, Dubow served as vice president of clinical & medical affairs at Clintrex, a strategic advisory firm to the pharmaceutical industry, where he provided clinical, regulatory and business development support in the field of neurological diseases. Earlier positions included Chief Medical Officer at Marathon Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing therapies for neurological disorders, vice president, medical affairs at Cynapsus Therapeutics, and medical director, neuroscience clinical development at AbbVie. Dubow is a board-certified neurologist who received his MD from the Northwestern University Feinberg School of Medicine. He has numerous peer-reviewed publications in neurological disorders and has served as a reviewer for various neurological journals.

“I was attracted to Avadel by the therapeutic and commercial potential of FT218,” says Dubow. “The standard-of-care in narcolepsy, though efficacious, is limited by an inconvenient dosing schedule. Despite that, its sales exceeded $1.4 billion in 2018 indicating both the need and opportunity for new treatment options. I believe a differentiated and highly efficacious therapy will be well positioned for success for treating this condition. I look forward to contributing a meaningful role in bringing FT218 to patients who could benefit from it.”