US regulators have approved the first new drug for children with ADHD in the last decade, which causes inattention, hyperactivity and impulsivity.
Food and Drug Administration OK’d Qelbree (KELL’-bree) late Friday evening for the treatment of attention deficit hyperactivity disorder in children aged 6 to 17 years. It comes in a capsule that is taken every day.
Unlike almost all other drugs for ADHD, Qelbree is not a stimulant or control substance, which is more difficult to abuse than the old drugs. This has been the case with earlier ADHD treatments such as Ritalin, almost all of which contain the stimulants amphetamine or methylphenidate.
Qelbree, developed by Supernus Pharmaceuticals in Rockville, Maryland, warns of the potential for suicidal ideation and behavior in less than 1% of drug study volunteers.
Supernus will not disclose the price of the drug list, but it will certainly be higher than many cheap generic ADHD pills.
ADHD affects an estimated 6 million American children and adolescents. For many, problems include attention-grabbing tasks, gloom, and impulsivity.
Experts say the drug may appeal to parents who do not want to give their child stimulants.
It can also be an option for children who have drug abuse problems, do not like the side effects of stimulants or need additional therapy. medicine
Goodman says most patients with ADHD who are currently on medication are prescribed long-acting stimulants that are more difficult to abuse than the initial, fast-acting options.
In a major late-phase study funded by Supernus, 477 children aged 6 to 11 years took the drug over six weeks. Symptoms of inattention և hyperactivity were reduced by about 50% compared with the placebo group. Qelbree, also known as viloxazine, helped some volunteers reduce their symptoms within a week. Common side effects include drowsiness, weakness, loss of appetite, and headache.
Supernus is currently in the testing phase for adults with ADHD. It is a much smaller group than children, but that market is growing as few adults now use ADHD drugs.
Viloxazine has been marketed as an antidepressant in Europe for decades, but has never been approved by the FDA. The manufacturer ended its sales nearly two decades ago because of its business, as popular tablets like Zoloft և Prozac dominated the market.
Follow Linda A. Johnson on Twitter: @LindaJ_onPharma
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