It's a mixed blessing! Idorsia published clinical data for the second phase 3 of insomnia drugs.

On July 6th, local time, Swiss pharmaceutical company Idorsia released its second phase 3 clinical data on insomniac patients with its double orexin receptor antagonist (DORA) daridorexant, with mixed results overall.
the study recruited 924 adult insomniacs to assess the effects of two doses of daridorexant (10 mg and 25 mg).
specific results, 25mg daridorexant can significantly improve sleep maintenance and subjective total sleep time.
these results were statistically significant in the first and third months and showed sustainable improvement.
in addition, the effect of the 25 mg dose on sleep start and daytime performance was numerically consistent with those observed in the first study, but not statistically significant.
the 10 mg dose group were positive in all four functional indicators, but the improvement range was less than 25 mg dose group, and no significant difference was achieved. side effects remained low
study, with the proportion of more severe cases occurring in different concentrations of the drug-administered and placebo groups.
April 20, 2020, Idorsia published the results of daridorexant's first Phase 3 clinically critical study, which showed that both 25 mg and 50mg daridorexant significantly improved sleep starting and sleep maintenance.
a 50 mg dose can also significantly improve daytime performance.
all the results were consistent during the three months of the trial.
take into account the 25 mg dose in both studies, which some analysts believe will provide regulators with a very promising picture of the drug.
but given that regulators usually take a very cautious approach when approving insomnia treatments, there are still some issues to consider.
daridorexant, source: Peter Welford, an analyst at Jefferies on The Idorsia website, said poor results in low-dose groups could have a positive impact on drug approvals, which could force the FDA to abandon low-dose options, increasing the probability of high-dose approvals.
whether the final declaration will be successful is unclear.
, about 30 percent of adults worldwide suffer from insomnia, and most of them experience insomnia for months to years.
DORA, unlike traditional insomnia drugs, has an inhibitory effect on the orexin signaling pathway.
Orexin is a hormone produced by the hypothalamus, discovered in 1998, that regulates sleep and awakens appetite.
currently, only two DORAs have been approved for insomnia in the world, becoming Belsomra in Mashadon and Dayvigo in Thetube.
reference source: 1, Idorsia announcs positive results in the second Phase 3 study of daridorexant 2, second PhIII study for Idorsia's sleep drug see s reeds sees, but raises new questions.