It has received orphan drug designation from the FDA because it may be clinically superior to the twice-nightly formulation of sodium oxybate already approved for the same condition. ON-SXB is under review at the FDA for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. But with ON-SXB, rates of headaches, nausea and dizziness were lower. The side effects of ON-SXB are similar to those of the twice-nightly version of sodium oxybate and include nausea, headache, vomiting, dizziness, involuntary urination and decreased appetite. For example, 72% of participants taking the highest dose of ON-SXB were considered much or very much improved, compared with 31.6% in the placebo group. In total, 222 narcolepsy patients, ages 16 or older, were randomly assigned to take ON-SXB, in varying amounts, or a placebo.Ĭompared with placebo, participants on the three highest doses of ON-SXB had significantly less daytime sleepiness, a decrease in weekly cataplexy attacks, lower self-rated sleepiness in everyday situations, and higher overall condition scores from their clinicians. The trial was conducted from November 2016 to March 2020 at 71 centers in the United States, Australia, Canada and Europe. “Although the labeling advises patients to remain in bed to take the second dose, falls leading to injury and, in some cases, hospitalization have been reported when patients rise from bed.” No-awakening alternative “A medication that is taken twice daily - in the morning and evening - is more challenging than a once-daily medication, but it’s even more problematic for a chronic medication requiring middle-of-the-night awakening,” Kushida said. When patients need to take medications more than once daily, they tend to miss doses: This problem has been seen with other conditions, including depression, schizophrenia, epilepsy, Type 2 diabetes, cardiovascular disease, chronic obstructive pulmonary disease and HIV. Waking in the middle of the night to take the medication can be highly disruptive, especially considering that patients typically already experience fragmented sleep and poor sleep quality.Ī study in Europe showed that 27% of patients with narcolepsy did not take sodium oxybate on the recommended time schedule. But because its half-life is approximately 30 minutes to 1 hour, a second dose is required 2 ½ to 4 hours after the first dose. Sodium oxybate is effective at treating multiple narcolepsy symptoms, including disrupted nighttime sleep. This collection of features can interfere with psychological and cognitive function and development it can also severely impede daily life, including school attendance, employment and social activities. All patients experience excessive daytime sleepiness, which can manifest as sleep attacks that last several seconds or minutes and can occur while talking, eating or driving.Ĭataplexy, which is another common symptom, is often triggered by strong emotions and sometimes causes falls. In addition to excessive daytime sleepiness and cataplexy, symptoms include disrupted nighttime sleep, sleep paralysis, and hallucinations when falling asleep or waking up. Narcolepsy is a chronic neurological disorder that affects between 135,000 and 200,000 people in the U.S. “Clinicians can be confident that a single bedtime dose of sodium oxybate has demonstrated efficacy for both objective and subjective symptoms of narcolepsy.” “Sodium oxybate has largely become a first-line treatment for patients with narcolepsy,” said Clete Kushida, MD, PhD, a professor of psychiatry and behavioral sciences. Eliminating the need for a second dose at night, ON-SXB could help patients adhere to the medication regimen, reduce the risk of falls leading to injury, and improve nocturnal sleep and overall quality of life. Its safety profile was favorable, with side effects that were similar to those caused by the twice-nightly version of sodium oxybate. In the trial, ON-SXB decreased cataplexy attacks and daytime sleepiness more effectively than a placebo, while increasing clinicians’ ratings of the overall condition of study participants. Sodium oxybate is approved by the Food and Drug Administration for the treatment of multiple narcolepsy symptoms, including excessive daytime sleepiness and cataplexy - sudden muscle weakness while awake. The drug the researchers were investigating, ON-SXB, is an extended-release version of sodium oxybate, which requires twice-nightly dosing. A new version of a narcolepsy drug that patients take once at bedtime - rather than at bedtime and again in the middle of the night - safely and effectively improved symptoms in a trial led by a researcher at Stanford Medicine.
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