After key patent loss, Supernus touts positive results for nonstimulant ADHD med Qelbree

A shortage of attention-deficit/hyperactivity disorder (ADHD) medicines has been ongoing for a year in the U.S. and has gained increased attention over the last few weeks with kids returning to school.

So the timing is right for Supernus to share positive trial results for its alternative, nonstimulant ADHD treatment, Qelbree, which was approved for children in 2021.

In a poster presented over the weekend at Psych Congress 2023, Qelbree was shown to sharpen the focus of children 6 and older when combined with a stimulant. It also was shown to improve efficacy in adult patients when used over many months, the company said.

In a phase 4 study of 110 children ages 6 to 17, Qelbree—when added to therapy with psychostimulants—provided significant improvement in ADHD symptoms regardless of whether it was dosed in the morning or the evening, Supernus said.

As for the other trial, which was an open-label extension of a phase 3 study that backed Qelbree’s approval for adults, the treatment provided improvement in ADHD symptoms in 159 patients over 265 days.

Another reason for the timing being fortuitous for Supernus to show the effectiveness of Qelbree is that the company lost patent protection for its seizure and migraine drug Trokendi XR earlier this year.

Trokendi, which was the company’s top-selling product in 2022, pulling in $261 million in revenue, has seen its sales plummet in the first half of this year by 60%.

There are approximately 16.1 million people in the U.S. who have ADHD, with between 10% and 30% of them having difficulty tolerating stimulant medications.

Shire’s Intuniv was the first non-scheduled ADHD med to win the FDA's blessing back in 2009. Since then, a suite of low-cost copycats has swept the market. 

Around this time a year ago, several producers of generic Adderall reported shortages of the tightly controlled treatment. Those shortages had a domino effect, creating shortages of other ADHD treatments such as Ritalin, Concerta, Focalin and Vyvanse.