dm+d

Unassigned

New Medicines

Insomnia in adults

Information

New molecular entity
Idorsia
Idorsia

Development and Regulatory status

None
Pre-registration (Filed)
Pre-registration (Filed)
Mar 21Filed in EU [10].
Jan 21NDA submitted to FDA [11].
Nov 20Idorsia plans to submit a regulatory application to the US FDA by end of 2020 [9].
Apr 20Analysts predict EU and US launches in 2022, with 60% and 75% chance of success, respectively [8].
Apr 20Second PIII study due to read out in Q3 2020 [7].
Nov 19Idorsia expects results from PIII trial (NCT03545191) will be available in H1 20. Results from the second study will follow shortly thereafter. In addition, a comprehensive clinical pharmacology program is to be conducted in parallel [5].

Category

A dual orexin receptor antagonist (DORA). If approved, will be first-in-class DORA in the UK.
The Great British Sleep Survey (2011) identified that 45.7% of adults have insomnia disorder (28,092,168 people) [1].
Insomnia in adults
Oral

Trial or other data

Apr 20PIII trial found that daridorexant, both 25 and 50 mg significantly improved sleep onset and sleep maintenance in 930 adult and elderly patients (39.1% ≥ 65 years) with insomnia, as measured objectively in a sleep lab by polysomnography. Daridorexant also significantly improved subjective total sleep time as measured daily with a patient diary at home [6].
Nov 19PIII trial (NCT03545191) has finished recruiting and due to complete collection of primary outcome data in Jan 20 [4].
Oct 19Efficacy and adverse events data from pooled analysis of two PII trials released by Idorsia. Results showed a significant (p≤0.0007) dose-dependent decrease in WASO at Days 1 & 2 (average decrease of wake time after sleep onset from baseline on the first 2 nights of treatment, measured by polysomnography). Reported mean reductions from baseline to days 1 and 2 for WASO were −28.99, −33.75, −39.64, and−45.49 min for ascending daridorexant doses (placebo, −20.98 min; zolpidem,−31.23 min), and were sustained at days 28 and 29 (−37.76, −43.74, −39.84, −46.97 min for ascending daridorexant doses; placebo,−33.80 min; zolpidem,−37.08 min). Daridorexant also significantly (p<0.05) decreased LPS (latency to persistent sleep) at doses 10 mg and higher in a dose dependent manner. Observed changes in mean LPS from baseline to days 1 & 2 were −26.88, −29.31, −36.14, and −36.41 min for ascending daridorexant doses (placebo, −22.02 min; zolpidem, −45.12 min). Reductions in LPS were sustained at days 28 and 29. A dose-response relationship was also demonstrated for WASO (p≤0.0001) and LPS (p≤0.025) [3].
Aug 18PIII extension study to evaluate the long term safety and tolerability of nemorexant in 1,260 adult and elderly patients with insomnia starts (NCT03679884) [2].
Jun 18The second PIII trial to evaluate the efficacy and safety of nemorexant in adult and elderly subjects with insomnia disorder is underway (ID-078A302; EudraCT2017-004643-20). It will enrol 540 adults (aged 18 to 64 years) and elderly (aged ≥ 65 years) patients in Germany and Finland [3].
Jun 18PIII trial to evaluate the efficacy and safety of nemorexant in adult and elderly subjects with insomnia disorder starts (ID-078A301; NCT03545191). 900 adults will be recruited in countries including the US & EU (not UK). This trial is a part of registrational programme which consists of two confirmatory studies together with a long-term extension study, in 1,800 patients with insomnia, designed to evaluate time to sleep onset, sleep maintenance, and next day performance, and providing long-term safety data. Collection of primary outcome data is expected to complete Oct 19 [2,3].

Evidence based evaluations