Hypersomnia is a condition when a person can sleep for 10-13 hours but still wake up feeling tried.know anyone like this?

Alkermes has begun its safety and efficacy trials of alixorexton for the treatment of narcolepsy type 1 and type 2, as well as idiopathic hypersomnia.

Alkermes announced today the initiation of the Brilliance Studies, a phase 3 program that will test the safety and efficacy of alixorexton compared with placebo in adults, according to a news release.

Alixorexton is an investigational treatment for narcolepsy types 1 and 2 and idiopathic hypersomnia (IH).

Narcolepsy is a chronic neurological disorder characterized by chronic daytime sleepiness. There are two types of narcolepsy: type 1 and type 2. Most patients with type 1 have cataplexy, whereas most patients with type 2 do not.

Cataplexy is sudden muscle weakness triggered by strong emotions, especially one that causes laughter. In some cases, some people continue doing whatever task they were in the middle of, for instance, typing, writing or driving. Such episodes can be dangerous, especially if they are driving.

Type 1 narcolepsy may also be associated with more severe symptoms such as sleep paralysis and vivid, dream-like hallucinations.

Idiopathic hypersomnia is another chronic neurological condition characterized by daytime sleepiness but long sleep hours. Patients often sleep for at least 10 hours and have trouble waking, called “sleep drunkenness.” The exact cause of this disorder is unknown.

Alixorexton is a once-daily, oral, selective orexin 2 receptor (OX2R) agonist.

Orexin is a neuropeptide produced in the lateral hypothalamus that regulates wakefulness by activating multiple “wake-promoting pathways.”

It’s thought that by targeting the orexin system, alixorexton could address excessive daytime sleepiness, whether deficient orexin is the cause of the disease or not.

“The initiation of the phase 3 Brilliance Studies program marks an exciting and important milestone for alixorexton,” Craig Hopkinson, M.D., MBChB, CMO and executive vice president of Research & Development at Alkermes, said in the news release. “Building on the positive findings observed in our large phase 2 program across both narcolepsy type 1 and type 2, we are entering this pivotal stage with confidence. We look forward to evaluating alixorexton in both once-daily and split-dose regimens as we seek to optimize efficacy, safety and dosing flexibility in the development of a potential new treatment option for patients and providers.”

The Brilliance Studies program consists of three, 12-week randomized, double-blind trials.

Brilliance NT1

Brilliance NT1 includes study 302 and study 304, each enrolling approximately 150 N1 patients combined across North America, Asia Pacific and Europe.

Participants will be randomized to receive one of two doses of alixorexton daily for 12 weeks.

The primary endpoint of each study will be to see if participants experience an increase in wakefulness, calculated by a change in mean sleep latency on the maintenance of wakefulness test (MWT).

A secondary endpoint will be measured by a meaningful change in Epworth Sleepiness Scale (ESS) score, mean weekly cataplexy rate (WCR), patient-reported outcomes related to fatigue, cognition, disease severity and incidence of adverse events.

Brilliance NT2

Brilliance NT2 includes study 303, which will enroll approximately 180 patients with N2 across sites in North America, the Asia Pacific, and Europe.

Efficacy will also be measured by a change in the MWT and ESS, as well as patient-reported outcomes.

Participants who complete the studies may be eligible to enroll in a long-term, open-label extension trial to further evaluate safety.