FDA Approves Novel Non-Stimulant Treatment for ADHD


Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. Food and Drug Administration (FDA) approved the company’s non-stimulant treatment for attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

Jack A, Khattar, president and chief executive officer of Rockville, Md.-based Supernus, said the company believes Qelbree (viloxazine extended-release capsules) is a unique alternative for the treatment of ADHD, which is often treated with medications that are considered a controlled substance.

“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. We are grateful to the patients, families and their care givers who participated in and supported our research,” Khattar said in a statement.

Qelbree, formerly known as SPN-812, is a serotonin norepinephrine modulating agent, a novel non-stimulant for the treatment of ADHD. The active ingredient in SPN-812, viloxazine hydrochloride, has an extensive safety record in Europe, where it was previously marketed for many years as an antidepressant, the company said.

The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1,000 pediatric patients from the age of 6 to 17 years.

Qelbree does come with a black-box warning. 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. Qelbree should not be taken by patients that also take certain anti-depression medicines, especially those called a monoamine oxidase inhibitor or MAOI, or certain asthma medicines.

Supernus resubmitted its New Drug Application to the FDA in February after receiving a Complete Response Letter from the regulatory agency last year. In the CRL, the FDA raised concern about the company’s in-house laboratory that conducts analytical testing, which had recently moved to a new location. In the NDA resubmission Supernus removed reference to its in-house laboratory and addressed other contents of the CRL. Following the receipt of the CRL, Supernus and the FDA held a Type A meeting in January 2021 to discuss the CRL and the requirements for the NDA resubmission. Once the NDA was accepted, the FDA reclassified the NDA as a Class I review to expedite the evaluation of the medication.

Between the time the company received the CRL and resubmitted its NDA, Supernus announced positive topline Phase III results for Qelbree that showed efficacy on both hyperactivity/impulsivity and inattention subscales with statistical significance in adult patients. The data from this study will be used to support an additional indication for Qelbree. Supernus plans to file a supplemental New Drug Application to the FDA in the second half of 2021.

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