FDA approves first new ADHD drug in a decade

pharmafile | April 6, 2021 | News story | Manufacturing and Production ADHD, FDA, paediatric 

The FDA have approved the first new drug for the treatment of attention deficit hyperactivity disorder (ADHD) in over a decade for paediatric patients.

The drug, Qelbree, was created by Supernus Pharmaceuticals and is a once-daily viloxazine extended-release sprinkleable capsule, for patients aged between 6 and 17.

Jack A Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals, said: “Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD.

“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 caregivers who participated in and supported our research.”

Unlike nearly all other ADHD medicines, Qelbree is not a stimulant or a controlled substance, making it harder to abuse than older ADHD drugs. Abuse has been a problem with earlier ADHD treatments, such as Ritalin, nearly all of which contain the stimulants amphetamine or methylphenidate.

The FDA approval followed the success of four Phase III clinical trials that studied over 1000 paediatric patients between the ages of 6 to 17.  

Key findings from the studies found that inattention and hyperactivity symptoms were reduced by about 50% compared to the placebo group. Qelbree, also known as viloxazine, helped reduce symptoms in some study volunteers within a week.

However, Qelbree does carry the boxed warning of higher rates of suicidal thoughts and behaviours, which were observed in under 1% of patients with ADHD during clinical trials. Qelbree-treated patients should therefore be monitored for worsening or emergence of suicidal thoughts.

Supernus Pharmaceuticals also announced positive results from a Phase III trial in adult patients with ADHD in December last year. They plan to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.

Kat Jenkins

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