Defense Department backs new study of Idorsia's Quviviq as a treatment for PTSD

Of a variety of medications for post-traumatic stress disorder (PTSD), antidepressants are the most commonly used. For many with PTSD, however, these and other treatments aren’t sufficient.

But a new answer may be on its way. A study sponsored by the Department of Defense (DOD) will test the effectiveness of Idorsia’s newly approved insomnia drug Quviviq in those with PTSD.

The link between insomnia and PTSD is well established. A study of U.S. active duty personnel from wars in Afghanistan and Iraq showed that 92% of those with PTSD reported significant levels of insomnia compared to 28% of those without PTSD.

“PTSD is bad. But if you have untreated insomnia, it can be much worse—more depression, more depressive rebound, more hospitalizations and unfortunately more suicide,” Christopher Lettieri, M.D., the senior medical director of Idorsia and a professor of medicine for the Uniformed Services University of the Health Sciences, said in an interview with Fierce Pharma.

Treating and studying those with PTSD and sleep disorders in his 28 years in the U.S. Army, Lettieri believes more treatment options are needed.

“On average, everyone’s on three to four psychoactive medications and they just weren’t doing real well,” Lettieri said.

In addition to antidepressants, other drugs used to treat PTSD include mood stabilizers, alpha blockers and fast-acting anti-anxiety medicines that provide short-term relief by calming the nervous system. Some states have specifically approved medical cannabis for the condition, according to the U.S. Department of Veterans Affairs, but the agency does not recommend that option, citing various concerns.

For its part, Quviviq was approved by the FDA in January 2022 but did not reach the market until later in the year as it had to be registered as a controlled substance.

In the DOD-backed phase 2 study, which will begin enrollment by the end of this quarter, Quviviq is one of three drugs that will be evaluated. The others are aging antidepressants Viibryd (vilazodone hydrochloride), which was approved in 2011, and Prozac (fluoxetine), which was approved in 1987.

The placebo-controlled study will measure the efficacy, tolerability and safety of the treatments on active duty personnel and veterans with PTSD. 

The investigators’ interest in Quviviq came from its mechanism of action as a dual orexin receptor antagonist (DORA), Lettieri said. While other insomnia meds work by sedating the brain, DORAs block the binding of wake-promoting orexins, tuning down overactive wakefulness.

“At its core, PTSD is an anxiety disorder. These people have the hyper-aroused state of insomnia,” Lettieri said. “DORAs block that hyper-aroused state.”

While PTSD affects 7 in 100 veterans, it also affects 6 in 100 in the general population. Victims of assault and rape are susceptible along with first responders and other healthcare workers.

“It’s a very unrecognized problem in the United States,” Lettieri said.