The director of the Sleep-Wake Disorders Center at Montefiore Medical Center detailed the overall state of sleep care and the advantages the investigational FT218 brings to the growing pipeline.
At the 2021 SLEEP Virtual Annual Meeting, June 10-13, investigators presented multiple post-hoc analyses from the REST-ON study (NCT02720744) which evaluated the effect of FT218 on measures of excessive daytime sleepiness (EDS) in patients with narcolepsy subtypes 1 and 2. At the conclusion of the study, patients treated with the therapy showed improvement on maintenance of wakefulness test and Clinical Global Impression-Improvement scores greater than placebo.
FT218, an investigational, once-nightly, controlled-release formulation of sodium oxybate, also demonstrated the ability to maintain efficacy in patients with narcolepsy regardless of stimulant use. Although the investigational drug continued to show promising data at the meeting, there was a trough of research presented on other notable treatments such as pitolisant (Wakix; Harmony Biosciences) and solriamfetol (Sunosi; Jazz Pharmaceuticals).
To get a better understanding of how FT218 fits into the growing landscape, NeurologyLive sat down with Michael J. Thorpy, MD. Thorpy, the director of the Sleep-Wake Disorders Center at Montefiore Medical Center, also provided thoughts on the outlook of the current treatment pipeline, takeaways from this year’s meeting, and the transition to virtual education going forward.
Michael J. Thorpy, MD: FT218 is a formulation of sodium oxybate. What we’ve known since 2000 is that sodium oxybate is a very effective agent for the treatment of narcolepsy. Not only does it treat the main symptoms of excessive daytime sleepiness and cataplexy, but it also treats the other features of abnormal REM phenomena as well as disturbed nocturnal sleep. Oxybate is really the only drug that affects all the features of narcolepsy. It has become a first-line drug for the treatment of narcolepsy. Not only for those with cataplexy, but even those without cataplexy. This drug is a modification of sodium oxybate.
Typically, sodium oxybate is given twice at night at the beginning of the night, and then 2 and a half to 4 hours later. But FT218 is a once nightly formulation of sodium oxybate. The data presented at the meeting looked at the efficacy of FT218, its effect on sleep quality and other abnormal REM phenomena. The data shows that FT218 is an effective drug for the treatment of excessive daytime sleepiness as well as cataplexy and disturbed nocturnal sleep. It has that advantage of only being needed to be given once at night so that patients don’t have to wake up in the middle of the night to get a second dose.
It’s a very exciting time because in the past, we’ve been limited in the number of medications at our disposal. In fact, the first medications that were used for narcolepsy were just for sleepiness. They sort of have a blunderbuss approach. They didn’t only treat sleepiness, but they also caused stimulation of other body systems such like cardiovascular, gastrointestinal, or psychological factors. What’s happened in the last few years is that we’ve been able to have drugs available to us that are more specific to the sleep-wake process and affect daytime sleepiness and cataplexy. They don’t have too much in terms of side effects and they’re more specific to narcolepsy.
At SLEEP 2021, what we found is that we’re beginning to get more information on the efficacy and administration on a number of these newer drugs, as well as what aspects of narcolepsy and particular symptoms they’re most effective for. It’s an exciting time in narcolepsy because we’re starting to see the development of new, more specific drugs for the space, which is going to help replace those older drugs that had greater side effects.
The data on how effective these drugs are is always important, and of course with any new drugs as well. From the meeting, we’re finding that there are new medications not only for narcolepsy, but for insomnia. One of the areas we’ve been particularly interested in is orexins. Although there’s not much on orexin agonists, there is a presentation showing its effect on sleep. It’s important to understand the efficacy of an orexin agonist. There have been a number of these types of drugs developed in the past, but at this meeting the presentation was of some new forms that are undergoing very early stages of investigation. It’s interesting to see that there’s this continuous pipeline of new drugs becoming available to us for the treatment of sleep disorders, not only narcolepsy and idiopathic hypersomnia, but also insomnia itself.
I’m delighted for this meeting and pleased to see that there are so many participants with so much research presented. Last year there was a bit of discomfort associated with this type of virtual meeting, and of course many physicians were so caught up with dealing with the pandemic that some of the research got dropped behind. But now that we’re coming out of the pandemic and people are more comfortable getting back to their research and presentations, these types of virtual meetings are going to play a part now. Whether we get back entirely to physical meetings I don’t know. There may always be a place to have some digital and virtual interaction, even at meetings where many people may physically attend. Things are certainly changing as we move to the future.
Transcript edited for clarity. For more segments of NeuroVoices, click here.