#Narcolepsy cataplexy places to live full
#Narcolepsy cataplexy places to live trial

“There are no FDA-approved drugs for IH, and I suspect LXB will be the first,” she says.ĭr.

#Narcolepsy cataplexy places to live full

She adds that LXB is also being reviewed by the FDA for use in managing idiopathic hypersomnia (IH), an uncommon sleep disorder characterized by excessive daytime sleepiness despite a full night’s rest. We want to raise awareness that patients don’t have to live with an impaired quality of life.” Foldvary-Schaefer says, “we now have more and safer options for managing narcolepsy and its associated symptoms, including drugs with different mechanisms of action. “Although the older stimulants were at least partially effective for many patients,” Dr. In addition to LXB, two other drugs with unique mechanisms of action were recently approved by the FDA for narcolepsy: solriamfetol, a norepinephrine-dopamine reuptake inhibitor, and pitolisant, an H 3 antagonist/inverse agonist. “Side effects are the same as with the older formulation, such as headache, nausea and dizziness, but the overall safety profile is superior because it doesn’t contribute to total daily sodium intake,” she says.Īdvertising Policy Expanding armamentarium for narcolepsy - and idiopathic hypersomnia Foldvary-Schaefer expects that LXB, taken as a liquid in two separate doses at night, will replace the higher-sodium formulation because it is safer to use over the long term. However, because of its high sodium content, SXB may increase the risk for hypertension and could impact disorders such as obesity and diabetes, which are common comorbidities in patients with narcolepsy.ĭr. “Sodium oxybate has been designated as a standard of care for narcolepsy by the American Academy of Sleep Medicine,” she continues, “and it has been proven effective in managing these symptoms.” The drug is scheduled at a lower level than traditional stimulants such as amphetamines, which can have cardiovascular effects. “Patients need to be on medications for life to manage symptoms that impair QOL, productivity and social functioning,” Dr. Associated cataplexy, or sudden muscle weakening, affects about 70% of people with narcolepsy and typically presents in the teens or 20s. “Further, most patients have persistent symptoms despite optimized medical therapy.”Īlthough onset typically occurs in the second or third decade of life, a 13-year average delay in diagnosis means that clinicians may see patients with seemingly new-onset narcolepsy in their 40s and beyond. “Narcolepsy is a neurologic disorder affecting approximately 1 in 2,000 people in the U.S., and we believe it is grossly underdiagnosed,” says Dr. Patients were then randomized to receive placebo or LXB for a two-week randomized, double-blind withdrawal phase to assess QOL.

#Narcolepsy cataplexy places to live trial

The trial first ran for 12 weeks in an open-label, optimized treatment-and-titration phase, and then for two weeks in a stable-dose phase.

The study mimicked real-world conditions in that patients who were taking traditional SXB were transitioned to the lower-sodium formulation, with the dose titrated based on efficacy and tolerability. The platform presentation was a follow-up to the recent publication in Sleep of primary efficacy and safety results of a phase 3 multicenter, randomized, placebo-controlled, double-blind withdrawal study of LXB in 134 adults with narcolepsy with cataplexy. QOL was measured with the 36-item Short Form Health Survey Version 2 (SF-36) and the 5-level EuroQol 5-Dimensions Self-Report Questionnaire (EQ-5D-5L). Foldvary-Schaefer, Director of Cleveland Clinic’s Sleep Disorders Center. “Quality of life worsened among patients randomized to placebo during a two-week withdrawal period, but it remained stable in participants who continued LXB treatment,” says Dr. We do not endorse non-Cleveland Clinic products or services Policy Advertising on our site helps support our mission. Cleveland Clinic is a non-profit academic medical center.