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2022-05-03| Trials & Approvals

A New Nonstimulant ADHD Medication For Adults Gets FDA Approval

by Reed Slater
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Supernus Pharmaceuticals, a company focused on developing products to treat central nervous system diseases, announced on April 29 that its nonstimulant, extended-release, attention deficit hyperactivity disorder (ADHD) medication, Qelbree, received FDA approval to treat adults diagnosed with the disorder. Qelbree is the first nonstimulant treatment option approved for adults in over 20 years. 

 

Growing Awareness of Adult ADHD

 

While ADHD is most commonly associated with young children unable to focus on their schoolwork, the pervasive disorder affects approximately 10 million adults in the United States. In fact, according to the CDC, children up to 16 years old only need to display six of the nine listed symptoms to potentially be diagnosed with ADHD, while patients 17 and older only need to display five of the nine symptoms to qualify. 

While ADHD has long been considered a “childhood disorder,” studies have shown that up to 90% of children with ADHD will continue to have it as adults. At least 10 million adults in the United States are diagnosed with ADHD, though the number is likely higher due to underdiagnoses. The most common treatment for ADHD is the use of psychostimulant drugs. The alternative to psychostimulant ADHD medications is nonstimulant medications. However, with fewer options and a longer response time, nonstimulant medications have long been considered a second-line treatment for ADHD. 

Before Qelbree’s FDA approval for use in adults with ADHD, there were only three major nonstimulant medications approved to treat ADHD; Atomoxetine, Clonidine, and Guanfacine. Atomoxetine is the only medication of these three approved for adult use. 

 

Qelbree Showed Positive Results in All Ages

 

In 2021, Qelbree received FDA approval for patients aged six to 17, and the company has been pushing for adult use approval ever since. Qelbree underwent four clinical trials, starting in 2017, which consistently showed positive results in ADHD patients of all ages. 

Supernus designed Qelbree as an extended-release capsule to compete with the long-lasting results of its psychostimulant opposition. Throughout the study, patients tolerated the daily dose pill well. However, like with most ADHD medications, Supernus advised of the risks involved in taking Qelbree. These risks include suicidal thoughts, heart rate and blood pressure increases, activation of mania or hypomania, and fatigue. 

 

An Alternative to Psychostimulants: Nonstimulant Medications

 

Millions of children and adults in the United States treat their ADHD with psychostimulant medications. The two most common psychostimulants used to treat ADHD are methylphenidate and amphetamines, both of which are listed as Schedule 2 drugs by the Drug Enforcement Agency. They are illegal to obtain without a prescription because of the risk of addiction. 

Though psychostimulants are proven to be effective in many cases, the risk of addiction has driven researchers to develop nonstimulant drugs to treat ADHD. Today, the nonstimulant ADHD medication market is still just a fraction of the size of the psychostimulant market. 

Atomoxetine (brand-name, Straterra) is the most well-known nonstimulant ADHD medication on the market, receiving FDA approval back in 2002. Straterra has remained a relatively popular prescription choice, with 6% of ADHD prescriptions being atomoxetine in 2015, but still a staggeringly low number compared to psychostimulants as a whole. 

With psychostimulants posing a risk as addictive substances, nonstimulant alternatives have long been an area of interest for doctors, patients, and researchers alike. Qelbree’s most recent FDA approval will provide the market with an even wider variety of choices in adult ADHD medication. 

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