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FDA Approves First New ADHD Drug for Children in Over 10 Years

This dateless image, provided by Supernus Pharmaceuticals in April 2021, shows bottles of different doses of the drug Qelbree. On Friday, April 2, 2021, the U.S. Food and Drug Administration approved a treatment for attention deficit hyperactivity disorder in children ages 6 to 17 (Supernus Pharmaceuticals via AP).

US regulators have approved a new drug for the first time in more than a decade for children with ADHD, which causes inattention, hyperactivity, and impulsivity.

The Food and Drug Administration OK’d Qelbree (KELL’-bree) to treat attention deficit hyperactivity disorder in children aged 6 to 17 late Friday. It is provided as a capsule that is taken daily.

Unlike almost all other ADHD drugs, Qelbree is not a stimulant or regulated drug, so it is more difficult to abuse than older drugs. This is a problem with early ADHD treatments like Ritalin. Almost all of Ritalin contains the stimulants amphetamine or methylphenidate.

Developed by Supernus Pharmaceuticals in Rockville, Maryland, Qelbree warns of suicidal ideation and potential behavior. This occurred in less than 1% of volunteers in drug research.

Supernus does not disclose the list price of the drug, but it is arguably more expensive than many cheap generic ADHD pills.

ADHD affects about 6 million American children and adolescents. For many, problems include paying attention, struggling to complete a task, fidgeting, and impulsivity.

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

Dr. David W. Goodman, director of the Suburban Psychiatry Associates near Baltimore and assistant professor of psychiatry at Johns Hopkins School, said he had drug abuse problems, disliked the side effects of stimulants, or had additional treatments. He said it could be an option for children in need. Of medicine.

According to Goodman, most ADHD patients currently taking the drug are prescribed long-acting stimulants, which are more difficult to abuse and get higher than the original fast-acting version.

In an important Supernus-sponsored late study, 477 children aged 6-11 years took the drug for 6 weeks. Symptoms of inattention and hyperactivity were reduced by about 50% compared to the placebo group. Kelbury, also known as viloxazine, helped some research volunteers relieve symptoms within a week. Common side effects include drowsiness, lethargy, loss of appetite, and headaches.

Supernus is in the late stage of trials in adults with ADHD. It’s a much smaller group than children, but the market is growing because few adults are currently taking ADHD medications.

Viloxazine has been marketed as an antidepressant in Europe for decades, but has never been approved by the FDA. With popular tablets like Zoloft and Prozac dominating the market, manufacturers discontinued for business reasons almost 20 years ago.

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Linda A on Twitter. Follow Johnson: @LindaJ_onPharma

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The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at Howard Hughes Medical Institute. AP is solely responsible for all content.

FDA Approves First New ADHD Drug for Children in Over 10 Years

Source link FDA Approves First New ADHD Drug for Children in Over 10 Years

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