Sleepless nights, especially when you have young children or, say, are perpetually worried about a seemingly never-ending pandemic, are nothing new to most people, but chronic insomnia that steals your ability to sleep takes this to another level.
As the FDA reviews its insomnia drug daridorexant, Idorsia is getting its awareness campaign off the ground early, launching a new Alliance for Sleep to help boost education and research into a condition that often goes undiagnosed and can severely affect quality of life.
The new alliance is co-chaired by Ruth Benca, M.D., Ph.D., chair of the Wake Forest School of Psychiatry and Behavioral Medicine, and Andrew Krystal, M.D., Ray and Dagmar Dolby distinguished professor and vice-chair for research at the Department of Psychiatry at the University of California, San Francisco's Weill Institute for Neurosciences.
The group under them is made up of healthcare professionals across a number of specialties including insomnia, sleep apnea, circadian rhythm disorder, integrative medicine and more. It recently met to talk over year-one priorities, which include a large-scale assessment of the impact and understanding of insomnia and working on new tools to “improve the dialogue around sleep.”
Benca sees sleep as the “third pillar of health” after diet and exercise, with chronic under-sleeping upping the risk of a host of serious conditions. Getting this right, just like diet and exercise, is crucial to overall health and can help knock down healthcare costs in the future by staving off disorders associated with the condition.
Insomnia—characterized by difficulty falling asleep, staying asleep and being severely tired during the day—is often under-diagnosed and under-treated, with Idorsia reckoning that around 70% of people with persistent insomnia never seek medical help.
The condition can affect many aspects of people’s lives, including the ability to concentrate as well as mood and energy levels. In the long term, insomnia is associated with serious health conditions such as psychiatric disorders, cardiovascular disease and Type 2 diabetes.
Idorsia told Fierce Pharma Marketing that the alliance aims “to fill in gaps in data” surrounding insomnia while also “deepening the understanding of the toll of insomnia as well as provide practical tools to address this important health issue.”
The biotech, a spinout from Big Pharma giant Johnson & Johnson's buyout of Actelion, is currently awaiting a potential FDA approval for its experimental insomnia drug daridorexant, with a decision expected in the coming months and potential launch in the first half of next year.
Last year, the drug aced a phase 3 trial in insomnia patients and linked the dual orexin receptor antagonist (DORA) to improvements in daytime performance. Idorsia is hoping to rival the market share of Merck’s insomnia therapy Belsomra, which shares a mechanism of action with daridorexant and was in fact the first DORA to market.
Sales for the Merck drug have been sluggish, however, making just $327 million in 2020, despite being on the market for seven years. Eisai is more optimistic its DORA—Dayvigo, launched last year in the U.S.—can hit blockbuster sales.
Merck has a long history with its insomnia campaigns, with one stretching all the way back to 2015, when it ran unbranded TV spots dubbed "Why So Awake" on national TV as well as in paid promotions on YouTube and in-office at healthcare practices around the country. Print ads appeared in national weekly and monthly magazines, while digital marketing included a WhySoAwake website, Twitter page and hashtag, and a mobile Sleep Guru app with tips for adopting healthy sleep habits. The website is still active today.
What has been holding Belsomra sales back is the extremely low cost of established, generic insomnia drugs, which have dragged down the overall value of the market for sleep medicines. All the companies with branded meds, including Idorsia, will hope a growing new market of DORA drugs and fresh campaigns can help turn the poor sales run around.