Idorsia announced positive topline results from a phase 3 study of daridorexant, an investigational dual orexin receptor antagonist, for the treatment of insomnia.

The multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of daridorexant in 930 patients (39.1% ≥65 years of age) with insomnia. Patients were randomized to receive daridorexant 25mg, 50mg or placebo orally once in the evening  for 3 months. The co-primary end points were the change from baseline to months 1 and 3 in sleep onset, as measured by a decrease in latency to persistent sleep, and sleep maintenance, as measured by a decrease in wake time after sleep onset. A key secondary end point was subjective total sleep time (sTST), measured daily with a patient diary at home.

Results showed that daridorexant 25mg and 50mg significantly improved sleep onset and sleep maintenance at months 1 and 3 compared with placebo, which was assessed objectively in a sleep lab by polysomnography. Additionally, both doses of daridorexant significantly increased sTST from baseline. Patients treated with daridorexant 50mg also demonstrated a significant improvement in daytime performance at months 1 and 3.

The safety profile of daridorexant was found to be comparable to placebo. The most frequent treatment-emergent adverse events (≥3% higher than placebo) reported were nasopharyngitis and headache. Moreover, daridorexant was not associated with next morning residual effects, rebound insomnia, or withdrawal symptoms upon discontinuation.


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Detailed study results will be made available through scientific disclosure at upcoming congresses and in peer reviewed publications. Results from a second phase 3 study evaluating the 10mg and 25mg doses are expected in the third quarter of 2020.

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For more information visit idorsia.com.

This article originally appeared on MPR