Eisai Co. and Purdue Pharma presented data at the Sleep Research Society’s Conference regarding their lemborexant for the treatment of insomnia. The meeting was held in Clearwater Beach, Florida.
Eisai and Purdue Pharma presented data at the Sleep Research Society’s Conference regarding their lemborexant for the treatment of insomnia. The meeting was held in Clearwater Beach, Florida.
The two companies presented data from SUNRISE 2, a 12-month multicenter, global, randomized, controlled, double-blind, parallel-group trial of the efficacy and safety of lemborexant in 949 adults ranging in age from 18 to 88 years. All had insomnia disorder, defined as difficulty falling asleep and/or staying asleep. About 28 percent of the patient randomized and treated were 65 years of age or older.
The trial was constructed so that in the first six months, patients received either lemborexant 5 mg, lemborexant 10 mg, or a placebo. The primary and key secondary efficacy endpoints were measured by self-reporting electronic sleep diaries.
At the end of the six months, the study found that patients treated with either dose of lemborexant had statistically significant improvement in patient-reported (subjective) sleep onset latency (sSOL), which was the primary efficacy endpoint, and subjective sleep efficiency (sSE) and subjective wake after sleep onset (sWASO), the trial’s key secondary endpoints.
Most side effects were mild to moderate. The most common adverse event was somnolence, headache, and influenza. The discontinuation rates based on side effects was comparable between the placebo and 5 mg lemborexant patients, but higher, 8.3 percent, for the 10 mg lemborexant group.
“These findings add to the growing body of clinical data supporting the development of lemborexant for the treatment of insomnia, and we look forward to presenting 12-month results from the study in a future scientific forum,” stated Lynn Kramer, chief clinical officer and chief medical officer, Neurology Business Group, Eisai.
SUNRISE 2 is one of two Phase III trials of lemborexant the two companies are conducting. They supported the New Drug Application (NDA) filed with the U.S. Food and Drug Administration (FDA) on December 27, 2018. An application is also expected to be filed in Japan in fiscal year 2018.
Lemborexant was discovered and developed in-house by Eisai researchers. The drug inhibits orexin signaling by binding to both orexin receptor subtypes. Normally, orexin signaling is believed to promote periods of wakefulness. But in people with sleep-wake disorders, the orexin signaling that regulates wakefulness is believed to be malfunctioning.
In earlier studies, the drug improved sleep with no “hangover effects” after waking up and “no grogginess” if the individual wakes up during the night.
At least one of the earlier trials compared lemborexant head-to-head against an extended-release formulation of zolpidem, which is marketed under various brand names such as Ambien, Edluar and Intermezzo, as well as generic formulation. In that trial, lemborexant was more effective in keeping patients over the age of 55 asleep through the night.
Other studies have also compared lemborexant to zopiclone, another sleep medication sold as Imovane, Zimovane and Dopareel. These evaluated the subjects’ driving ability in the morning after a bedtime dose of the drugs. Lemborexant patients didn’t show much difference, while those receiving zopiclone had a significant increase in what is called standard deviation of lateral position—weaving.
Some studies have evaluated the drug’s effect on “body sway,” and others looked at postural instability, which is a predictor of falls in older people. Noise threshold was studied as well, referring to the amount of sound needed to wake patients up. There was no difference there, but patients receiving lemborexant fell asleep more easily.
