QuviviqInsomnia in adults
New molecular entity
Development and Regulatory status
May 22Filed with MHRA using European Commission Decision Reliance Procedure .
May 22Approved in the EU for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning. The recommended dose of QUVIVIQ is one tablet of 50 mg once per night, taken orally in the evening within 30 minutes before going to bed .
May 22Launched in US .
Feb 22Recommended for EU approval by CHMP “for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning”. Quviviq will be available as 25 mg and 50 mg film-coated tablets .
Jan 22The launch campaign for daridorexant has begun in the US, although because it has been classed as a controlled drug, it won´t reach the market until May 
Jan 22Approved in US for treatment of adults with insomnia. US FDA has recommended that QUVIVIQ be classified as a controlled substance and it is anticipated to be available to patients in May 2022, following scheduling by the US Drug Enforcement Administration .
Mar 21NDA submitted to FDA in Jan 21 .
Mar 21Filed in EU .
Jan 21NDA submitted to FDA .
Nov 20Idorsia plans to submit a regulatory application to the US FDA by end of 2020 .
Apr 20Analysts predict EU and US launches in 2022, with 60% and 75% chance of success, respectively .
Apr 20Second PIII study due to read out in Q3 2020 .
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 .
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) .
Insomnia in adults
Trial or other data
Jan 22Two RCTs (NCT03545191; n=930 and NCT03575104; n=924) provide evidence of daridorexant efficacy on objective sleep induction and maintenance, on patient-reported sleep quantity and quality, and (at dose of 50 mg) on daytime functioning, with favourable safety profile .
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 .
Nov 19PIII trial (NCT03545191) has finished recruiting and due to complete collection of primary outcome data in Jan 20 .
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) .
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) .
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 .
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].