Reviewing the Benefits of a New Therapy Option for Narcolepsy

Michael Thorpy, MD, professor of neurology, Albert Einstein College of Medicine, reviews research presented at the 2021 Sleep meeting, examining a new agent for narcolepsy called FT218, and explains how patients treated with this new option experienced statistically significant improvements in excessive daytime sleepiness and weekly cataplectic episodes. 

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Welcome back to PopHealth Perspectives, a conversation with the Population Health Learning Network, where we combine expert commentary and exclusive insight into key issues in population health management and more.

Today, we are joined by Dr Michael Thorpy. Dr Thorpy reviews research presented at the 2021 Sleep Meeting and examines a new agent for narcolepsy called FT218. He explains how patients treated with this new option experienced significant improvements in excessive daytime sleepiness, as well as weekly cataplectic episodes. Dr Thorpy?

Hello, I'm Michael Thorpy. I'm a professor of Neurology at Albert Einstein College of Medicine and director of the Sleep-Wake Disorders Center at Montefiore Medical Center in New York.

At the 2021 Sleep Meeting held by the American Association of Professional Sleep Societies, there were a number of abstracts presented on the topic of a new agent for the treatment of narcolepsy, called FT218.

One of the studies that was the main study looking at its effectiveness in treating the symptoms of narcolepsy. Now, sodium oxybate is a medication that's been around since 2000 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, but it requires twice-nightly dosing, a dose at the beginning of the night, and then a dose halfway through the night.

This new agent, FT218, is still sodium oxybate, but it's in a slow-release form, so that it only needs to be given once at night, at the beginning of the night. This prevents patients from having to wake up in the middle of the night to take a second dose.

As it's a new formulation of sodium oxybate, it was important to determine whether it was efficacious for treating the main symptoms of narcolepsy. In the study, a pivotal study, phase III study for FT218, sodium oxybate was studied in patients who have both narcolepsy type 1 and narcolepsy type 2.

There were 212 patients who received either the placebo or FT218, and it was randomized, placebo-controlled, multicenter study. It was in patients over the age of 16 years. Excessive daytime sleepiness was assessed by means of the maintenance of wakefulness test, which is an objective test for alertness.

What was shown was that FT218 was superior to placebo at all doses studied, at 6 grams, and 9 grams, 7.5 grams. Patients who received FT218 were very much improved overall in terms of their narcolepsy. A clinical global impressions scale of improvement showed again significant improvement at the 9 grams, 7.5, and 6 grams.

Weekly cataplectic episodes were also assessed in those patients with NT1 who had cataplexy, and again, FT218 was statistically significant in improving cataplexy at the 9-gram dose, 7.5-gram dose, and 6-gram dose.

Overall, a pivotal study for FT218 showed statistically significant improvements in the 3 main parameters that were looked at, excessive daytime sleepiness, overall improvement in patients with narcolepsy, and weekly cataplectic episodes.

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