A Sleeping Giant?: Quviviq

When a promising drug candidate with a research and development journey 20 years in the making achieves regulatory approval, it is a good bet that little will be shortchanged in its market launch—those calculated and artfully planned efforts to finally reach patients in the real world who can benefit. For Idorsia Pharmaceuticals US Inc. (Idorsia US) and its new oral treatment for insomnia, Quviviq (daridorexant), which became available at US pharmacies in May after its approval a few months earlier, that has certainly been the case. Quviviq is a Schedule IV controlled substance that, unlike other drugs, is thought to target one of the biological causes of the sleep-robbing and often misunderstood condition: overactive wake signaling. On its long road to approval, Quviviq was tested in more than 25,000 different molecule combinations, as researchers worked to carefully perfect its therapeutic window and eventual eight-hour half-life—designed to help patients get to sleep and stay asleep longer, but also feel less tired the next day.

It is that latter element—reducing daytime sleepiness—that, according to Idorsia, differentiates Quviviq from others in the relatively new dual orexin receptor antagonist (DORA) class, which consists of competitors from Merck (Belsomra) and Eisai (Dayvigo). In a pair of Phase III clinical trials, Quviviq showed significant improvement over placebo in sleep onset, sleep maintenance, and total sleep time, while also reducing daytime sleepiness.

“Sleep is about restoring your body—all that happens when you’re sleeping; but how you feel the next day is also important,” says Patty Torr, US president and general manager, Idorsia US.

Quviviq was originally developed by Actelion, the European biotech giant that was acquired by Johnson & Johnson in 2017. Actelion then spun out its drug discovery and early stage clinical development assets to form Idorsia, the Swiss-based parent company of Idorsia US. The latter’s commercial operations were established in Radnor, Penn., in March 2020 with the goal of shepherding a pathway to market in the US for Quviviq and other hopeful therapies in Idorsia’s pipeline.

FDA officially cleared Quviviq in January of this year for use in a population where reportedly 25 million people have a sleep disorder, but less than 12 million are on a prescribed medication to treat it. (Daridorexant was subsequently approved by the European Medicines Agency in May for adult patients with chronic insomnia and considerable impact in daytime functioning). Over the long-term, insomnia is known to be associated with numerous serious health conditions, such as psychiatric disorders, cardiovascular disease, type 2 diabetes, substance abuse, and dementia.

“Our drug is an orexin receptor antagonist, which is thought to moderate the sleep/wake signal rather than give you that knockout effect that many older prescription products do,” says Torr. “The most important thing about our product is the safety profile.”

In its pivotal registration trials, Quviviq, at the 50 mg dose in particular, demonstrated significant improvement in daytime sleepiness, and there was no evidence of dose-dependent increases in adverse events across the dosing range (the most common side effects reported with Quviviq were headache and sleepiness). The drug also showed a lack of withdrawal symptoms after stopping use, suggesting no physical dependence.

Quviviq was approved in 25 and 50 mg dosages, and is intended to be taken at night 30 minutes before going to bed (patients are urged not to take the drug unless they are able to stay in bed for at least seven hours).

Shooting for the stars

Believing strongly in its safety and efficacy profile, upon Quviviq’s US approval, Idorsia US had prepared a launch that could be considered as innovative as the treatment itself. As first chronicled in Pharm Exec’s May profile of Torr, named one of our 2022 Emerging Pharma Leaders, Idorsia US unleashed a series of wide-ranging premarketing “edutainment” and outreach and awareness campaigns, leveraging social media and other digital and online channels. They included partnerships with Hollywood A-listers, professional athletes, and others. The focus was on recognizing insomnia as a legitimate disorder, with a need for interventions that provide not just a restful night sleep, but a quality next day.

Headlining those initial efforts was the launch of the “Seize the Night & Day” campaign with Jennifer Aniston, an insomnia sufferer herself. The campaign, which showcases a website exploring the science behind insomnia, also features “Jen’s Sleep Story,” where Aniston speaks candidly about her personal struggles in an unscripted, intimate chat. Also introduced during the launch lead-up was a 30-second TV spot called “Time to Construct,” featuring Aniston and directed by Oscar-winning director, writer, and actor Taika Waititi (of Thor and Jojo Rabbit fame, to name a couple). In a separate campaign, Idorsia US, in mid-March, premiered “The Quest for Sleep,” a feature-length documentary, on Facebook, followed by select screenings in New York City and Los Angeles. Narrated by actress Octavia Spencer, who voices the role of sleep, the film has garnered almost 1.6 million views on YouTube as of late August. Also featured are NBA veteran and four-time champion Andre Iguodala and Olympic runner Emma Coburn.

More recently, with Quviviq now launched, Idorsia unveiled direct branded partnerships with actor Taye Diggs and skiing great Lindsey Vonn as “patient ambassadors.” Both are prominently featured on Idorsia US and Quviviq websites as well as across Quviviq social media channels, sharing their personal struggles living with insomnia, along with their experiences taking Quviviq. A DTC national TV ad featuring Vonn started airing in August and one featuring Diggs was slated to begin this month.

“Our goal is really to educate consumers, largely because insomnia is not necessarily seen as top of mind for healthcare providers to talk to their patients about. It’s usually an afterthought,” says Torr. “So we want to bring that conversation to the forefront and encourage patients who are having sleep problems to improve their self-advocacy when they’re having those exchanges with their physicians.”

Access and awareness

Quviviq was first commercially available on May 2 through a pharmacy services provider, before becoming available to all retail pharmacies for ordering a couple weeks later. The wholesale acquisition cost (WAC) for Quviviq is around $490 for 30 tablets. According to Idorsia, eligible patients with insurance may pay as low as $0 for the first 30-day prescription and as low as $25 for each subsequent 30-day refill. Survey statistics cited in Idorsia’s first-half 2022 investor’s meeting show awareness of Quviviq by healthcare providers is growing quickly. In June, for instance, awareness jumped 52%. Total prescriptions dispensed for the drug since its launch rose to more to 1,100 for the week of July 15 and has been rising steadily since, with 75% of scripts written for the 50 mg dose and 60% written with at least one refill (according to Idorsia, the drug gained 2,691 unique writers through July 8).

Time will tell if and when Quviviq could establish a dominant foothold in the DORA treatment market, but early tracking of the drug in weekly new-to-brand prescription (NBRx) numbers so far in 2022 may foretell a quick rise. For just the week of July 15, Quviviq notched 872 NBRxs, trailing Belsomra’s 1,543 that week and ahead of Dayvigo’s 532 for the same week. Belsomra generated sales of $318 million in 2021, while Dayvigo, launched in 2020, posted $67 million for fiscal 2021 and brought in around $86 million in the first three quarters of its current fiscal year. Forecasted revenue for Quviviq in 2026 is $1.05 billion. Idorsia CEO Jean-Paul Clozel, in published remarks, has stated that due to the large number of people suffering from insomnia, a new drug only has to have a market penetration of 15% to 20% to reach blockbuster revenues. The overall market for insomnia treatments in the US is projected to total $6.3 billion by 2030, according to Allied Market Research.

Primary care providers have shown to be more apt to prescribe DORAs for insomnia over other drugs classes, such as benzodiazepines and “Z-drugs” like Ambien.

Idorsia has partnered with Syneos Health to establish a contract sales team of about 500 specialty sales representatives aimed at reaching a broad group of healthcare professionals, including primary care providers. Globally, in addition to being the first DORA cleared for the EU market in insomnia, with product launch in Germany expected later this year, Quviviq is under regulatory review with Health Canada and SwissMedic. Recruitment for a Phase III clinical trial program in Japan was completed this year.

Read the profiles of all 2022 product launch selections here.

Michael Christel is Pharm Exec’s Group Managing Editor. He can be reached at mchristel@mjhlifesciences.com.