x

Health

FDA OKs First New ADHD Drug in Over a Decade for Children

U.S. regulators have approved the first new drug in over a decade for children with ADHD, which causes inattention, hyperactivity and impulsivity.

The Food and Drug Administration late Friday OK'd Qelbree (KELL'-bree) for treating attention deficit hyperactivity disorder in children ages 6 to 17. It comes as a capsule that's taken daily. 

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

Qelbree, developed by Supernus Pharmaceuticals of Rockville, Maryland, carries a warning of potential for suicidal thoughts and behavior, which occurred in fewer than 1% of volunteers in studies of the drug.

Supernus wouldn't disclose the drug's list price, but it's sure to be higher than the many cheap generic ADHD pills.

ADHD affects about 6 million American children and adolescents. For many, problems include trouble paying attention and completing tasks, fidgeting and impulsiveness.

Experts say the drug may appeal to parents who don't want to give their child stimulants.

It also could be an option for kids who have substance abuse problems, dislike the side effects of stimulants or need additional therapy, said Dr. David W. Goodman, director of Suburban Psychiatric Associates near Baltimore and an assistant professor of psychiatry at Johns Hopkins School of Medicine. 

Goodman said most ADHD patients taking medication currently are prescribed long-acting stimulants, which are harder to to abuse to get a high than the original, fast-acting versions.

In a key late-stage study funded by Supernus, 477 children ages 6 to 11 took the drug for six weeks. 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. Common side effects include sleepiness, lethargy, decreased appetite and headache. 

Supernus is in late-stage testing for adults with ADHD. That's a much smaller group than children, but that market is growing because few adults currently take ADHD medicines. 

Viloxazine was sold as an antidepressant in Europe for several decades, but was never approved by the FDA. The maker ended sales for business reasons nearly two decades ago, as popular pills like Zoloft and Prozac came to dominate the market.

RELATED

JACKSON, Miss — Mississippi lawmakers are sending their governor a bill that would create a medical marijuana program for people with serious medical conditions.

Top Stories

Associations

ASTORIA – The Pancyprian Choir of NY held its first meeting of 2022 and shared best wishes for the New Year with their annual cutting of the traditional vasilopita at Dionysos Taverna in Astoria on January 24.

Associations

BRONX, NY – In a festive atmosphere, the traditional cutting of the vasilopita was held by the Northern Chios Society of Pelineon Agia Markella in the community hall of Zoodohos Peghe Greek Orthodox Church in the Bronx on January 23.

Society

ATHENS – A major snow storm that had been predicted for days still caught residents in Greece offguard and the New Democracy government scrambling for answers as to why motorists were stuck for hours on major roads.

Video

Democrats Eye Supreme Court Pick to Revive 2022 Prospects

Democrats stung by a series of election year failures to deliver legislative wins for their most loyal voters hope they'll be buoyed by the prospect that President Joe Biden will name the first Black woman to serve on the Supreme Court.

Enter your email address to subscribe

Provide your email address to subscribe. For e.g. abc@xyz.com

You may unsubscribe at any time using the link in our newsletter.