FDA clears Qelbree, first new ADHD drug for children in more than a decade

FDA approved viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals), its first drug approval for children with attention-deficit hyperactivity disorder (ADHD) in more than a decade.

Jack Khattar

The sprinkleable non-stimulant medication is indicated for pediatric patients 6 to 17 years old. “Capsules can be opened and sprinkled on a teaspoonful of applesauce or swallowed whole. This makes it easier for patients — like a young child — who might have difficulty swallowing a capsule whole,” Jack Khattar, president and CEO of Supernus, told FormularyWatch®.

Related: FDA clears first non-drug option to treat ADHD in children

Based on the efficacy demonstrated in Supernus’s clinical trials, “We believe Qelbree offers a unique new alternative for the treatment of ADHD,” Khattar said in a press release issued on April 2. “Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile.”

Khattar expects Qelbree to be available this quarter but declined to reveal the drug’s wholesale acquisition cost. “Supernus doesn’t comment on pricing of new products before they are launched,” Khattar said, adding that Qelbree will be priced comparably to other ADHD products in the market. “We plan to have a robust patient access program available at launch, including a copay assistance program,” Khattar said.

Related: FDA approves Ponvoy, once-a-day oral drug for MS

Qelbree’s approval in based on data from an extensive development program consisting of four Phase 3 clinical trials that studied more than 1,000 pediatric patients, ages 6 to 17.

In December, Supernus announced positive results from a Phase 3 trial in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.

Qelbree may increase suicidal thoughts and actions in some children with ADHD — especially within the first few months of treatment or when the dose is changed, Supernus said. Qelbree is also contraindicated for patients who also take certain antidepression medicines— especially monoamine oxidase inhibitors — or certain asthma medicines.

Read more: FDA clears first generic treatment for severe hypoglycemia