Once-nightly sodium oxybate was associated with a statistically significant reduction in cataplexy episodes among patients with narcolepsy, explained Michael Thorpy, MD, director of the Sleep-Wake Disorders Center at Montefiore Medical Center and professor of neurology at Albert Einstein College of Medicine.
At SLEEP 2022, Michael Thorpy, MD, director of the Sleep-Wake Disorders Center at Montefiore Medical Center and professor of neurology at Albert Einstein College of Medicine, discussed the results of the REST-ON trial, which focused on the effects of FT218 in patients with narcolepsy.
Transcript
Can you discuss the results of the REST-ON trial?
The REST-ON trial is a trial that was done by a pharmaceutical company called Avadel. It was with this medication called FT218, which is a once-nightly form of sodium oxybate. Sodium oxybate we've had available to us since 2002, so we have a lot of experience with it. But one of the difficulties with the medication is that it needs to be taken twice at night and many patients don't want to wake up in the middle of a night to take a second dose of the medication. So this new medication, FT218, is a once-nightly formulation of sodium oxybate; the patient takes it prior to going to bed at night and then the 1 dose will serve them through the night and relieve their daytime symptoms of narcolepsy.
The study that was done was a parallel design study comparing placebo against FT218. What they looked at was the effect on sleepiness during the daytime. The prime outcome measure was an objective measure of sleepiness called the Maintenance of Wakefulness Test. They showed significant improvements in the Maintenance of Wakefulness Tests, indicating that patients are able to remain more awake and alert during the day after receiving the once-nightly form of sodium oxybate at night.
In addition to that, they looked at cataplectic episodes and showed that the number of cataplectic episodes were reduced. There was a statistically significant reduction in the cataplexy that patients were experiencing. The results of the study indicated that the once-nightly formulation was as effective as the twice-nightly administration of sodium oxybate, but had that added benefit that patients only have to take 1 dose rather than taking 2 doses.
What implications might these findings have for clinicians treating patients with narcolepsy?
Patients, at the moment, have a variety of medications that are available to them for the treatment of narcolepsy, but oxybate is regarded as the most effective medication for treating not only the sleepiness during the daytime but also the cataplexy. Also, it improves the quality of sleep at night because most patients—particularly those with type 1 narcolepsy—when they have cataplexy also have very disturbed sleep at night, and oxybate is very effective at improving that. But a lot of patients have difficulty taking the current dose form of oxybate, which requires a second dose 2-and-a-half to 4 hours after the first one, so they're taking it in the middle of the night. Some patients have difficulty in awakening to take that second dose. So, for some patients, the twice-nightly formulation leads to reduced benefit for the patient because they may only be able to take 1 dose of it.
The new formulation of the once nightly form of sodium oxybate has that advantage that patients just need to take that 1 dose before going to bed, so it's much easier for the patient and they won't forget to take a second dose because the second dose isn't needed, and they won't have the need to awaken in the middle of the night to take another dose. It's a much more patient-acceptable format for oxybate.
Specialty Pharmacists at the Forefront: Elevating Care for Rare Diseases
May 1st 2024In the US, a disease is considered rare when it affects fewer than 200,000 persons, or 1 in every 1500 individuals, with an estimated total of 25 to 30 million Americans overall living with a rare disease at any given time.
Read More
Tackling Health Inequality: The Power of Education and Experience
April 30th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our final episode of this limited series and our conversation with Janine Jelks-Seale, MSPPM, director of health equity at UPMC Health Plan.
Listen
Latest Advances and Updates of Treatment in the Real World at AUA
May 1st 2024The annual meeting of the American Urological Association (AUA) not only presents the newest therapies coming out but showcases the latest in how treatments are being used in the real world, said Stephen Freedland, MD, of Cedars Sinai.
Read More
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
AUA to Focus on Inclusive Care, Robotic Surgeries, and Future of Urology at 2024 Annual Meeting
May 1st 2024The American Urological Association (AUA) 2024 Annual Meeting will highlight the latest innovations and future trends in urology, featuring dynamic plenary sessions, educational opportunities for providers, and discussions on cutting-edge treatments and global health initiatives.
Read More