Eisai, partner Purdue hit phase 3 goals in sleep drug trial

Japanese pharma Eisai and traditional pain biopharma Purdue have posted positive late-stage results from their partnered sleep medication lemborexant.

The pair originally penned a deal to split the costs of the dual orexin receptor antagonist back in 2015, with both companies believing it could become a disruptive force on the market for sleep aids.

And today, it’s showing a topline sneak peek at the phase 3 data, which they hope will help prove this out.

In this pivotal test, known as Sunrise 1, the experimental sleep and wake regulation drug was pitted against an extended-release form of zolpidem, now a generic, as well as a dummy pill.

The trial was looking older patients over 55 with difficulty staying asleep through the night. The test was measuring the change from baseline in “both sleep onset and sleep maintenance variables,” including the time spent awake in the second half of the night, which the companies say is a common complaint, especially in the elderly.

The study used objective polysomnography (PSG) data to gauge whether 5mg and 10mg lemborexant were better than zolpidem ER 6.25mg, as well as against placebo.

The details of the data are not yet being shared, and we only know it hit its primary and “key secondary” endpoints (read: it may not have hit all of the secondaries, but we don’t know that yet), against the two therapies.

Full results are slated to be shared at an “upcoming medical meeting in 2018.”

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Both say that lemborexant appears to “impact an underlying reason for a patient’s inability to sleep well,” and acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by “dampening wakefulness,” but without stopping people from being able to wake to things like alarms clocks or fire alarms.

“Our aspiration for lemborexant is to bring to patients suffering from sleep disorders a treatment for sleep and wake regulation that improves their ability to sleep through the night but allows patients to function if they awaken during the night, or when they wake in the morning,” said Lynn Kramer, M.D., chief clinical officer and CMO, neurology business group at Eisai.

“Knowing the unmet needs with respect to the risk of falls and motor vehicle collisions, especially among older patients, Eisai and Purdue scientists were challenged to discover a better option for treating sleep disorders.”

“Our confidence in lemborexant as a potential treatment for patients living with sleep disorders is strengthened with these data,” adds Craig Landau, M.D., president and CEO of Purdue Pharma. “We look forward to continuing to leverage our expertise in drug development and commercialization as we partner with Eisai to bring this new treatment to patients.”

The company also gave some details on phase 1 trials, mainly around safety, on other sleep areas it is looking to serve. It’s also got a phase 2 for lemborexant in patients with irregular sleep-wake rhythm disorder, and mild to moderate Alzheimer's dementia, which is already underway.