“The excellent results seen in this Phase III study of 3-month duration suggest that daridorexant can fulfill this significant need for patients with insomnia,” said Dr. Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital.
Idorsia announced on Monday that its experimental insomnia drug, daridorexant, has shown positive results in a late-stage clinical trial.
In its first Phase III study examining 25mg and 50mg doses of daridorexant in adult and elderly patients, the participants were able to fall asleep and stay asleep, according to Reuters. Additionally, the 930 subjects saw an improvement in their daytime performance, and there was no residual effect documented in the morning. Idorsia stated that the dual orexin receptor antagonist did not appear to cause withdrawal symptoms when it was stopped.
Chief Executive Jean-Paul Clozel told Reuters that he was “stunned” by the results. Back in February of this year, he announced that the company would be keeping its plans to seek regulatory approval for daridorexant, also known as DORA. He added that Idorsia was looking to launch the drug worldwide by the end of 2021 or the start of 2022.
“The excellent results seen in this Phase III study of 3-month duration suggest that daridorexant can fulfill this significant need for patients with insomnia,” said Dr. Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital.
In December 2019, Idorsia moved forward with its plans to expand the potential availability of daridorexant by linking up with Mochida Pharmaceutical Co., Ltd. Both companies entered an exclusive license agreement for the supply, co-development and co-marketing of daridorexant for insomnia and related disorders in Japan.
In addition to receiving a payment of 1 billion Japanese yen, Idorsia became entitled to three additional development and regulatory milestones, as well as sales milestones and tiered royalty payments based on the net sales made by Mochida. Both companies agreed that they would share the costs associated with the development of daridorexant.
“We are excited to have entered into the agreement with Idorsia for the supply, co-development and co-marketing of daridorexant,” said Naoyuki Mochida, president of Mochida. “Since general internal medicine and psychiatry, where insomnia patients are concentrated, are our priority areas, we believe that our experience will be of great use. We will endeavor to provide the drug to Japanese patients suffering from insomnia.”
A survey recently conducted by SleepHelp.org, an independently owned and operated sleep health education site, found that approximately 22% of people believe their sleep quality has worsened as a result of the COVID-19 pandemic. Overall, about 14% of people say they are sleeping less due to a fear of contracting the illness.
“Our findings indicate that COVID-19 concerns may be undermining Americans’ sleep, denying them the rest they need during this difficult moment,” wrote the SleepHelp.org authors of the survey. “But while the scale of these sleep troubles may be unsettling, our results should also normalize the stress that so many are feeling.”
In general, more than one-third of American adults are not getting enough sleep on a regular basis, according to the Centers for Disease Control and Prevention.
“As a nation we are not getting enough sleep,” said Wayne Giles, M.D., director of CDC’s Division of Population Health. “Lifestyle changes such as going to bed at the same time each night; rising at the same time each morning; and turning off or removing televisions, computers, mobile devices from the bedroom, can help people get the healthy sleep they need.”
According to the American Academy of Sleep Medicine and the Sleep Research Society, adults aged 18-60 years should sleep at least seven hours per night to maintain their well-being.
