FT218’s Effect on BMI Regardless of Stimulant Use: Asim Roy, MD

"Most often—and more often than not—weight reduction or weight stabilization is an important feature and can be a health benefit in most of these patients.”

At the 2021 SLEEP Virtual Annual Meeting, June 10-13, Avadel’s investigational sodium oxybate agent FT218, demonstrated its efficacy in a number of abstracts from the phase 3 REST-ON study (NCT02720744). The therapy improved excessive daytime sleepiness at all dose levels in patients with narcolepsy subtype 1 and 2 in measures such as maintenance of wakefulness test and Clinical Global Impression-Improvement (CGI-I) compared to placebo.

Investigators also confirmed that its effects on patients with and without stimulant use did not change. Both subgroups of patients who received FT218 rated sleepiness as much or very much improved on CGI-I at higher rates than those on placebo. Additionally, the drug had weight-related benefits, significant decreasing patients’ weight and body mass index (BMI) from baseline to week 13.

Trial investigator Asim Roy, MD, medical director, Ohio State Sleep Medicine Institute, sat down with NeurologyLive to discuss the significance of these additive benefits that FT218 brings to patients with narcolepsy in further detail.

REFERENCE

Avadel presents new clinical data from pivotal phase 3 REST-ON trial supporting clinical benefit of FT218 in patients with narcolepsy at SLEEP 2021. News release. Avadel Pharmaceuticals. June 9, 2021. Accessed June 17, 2021. https://www.globenewswire.com/newsrelease/2021/06/09/2244435/0/en/Avadel-Presents-New-Clinical-Data-from-Pivotal-Phase-3-REST-ON-Trial-Supporting-Clinical-Benefit-of-FT218-in-Patients-with-Narcolepsy-at-SLEEP-2021.html