- The United States Food and Drug Administration (FDA) has expanded its approval of a non-stimulant medication, viloxazine extended-release capsules, also known as Qelbree, for treating attention deficit hyperactivity disorder (ADHD) in adults.
- The FDA initially approved Qelbree in 2021 for treating ADHD in children ages 6–17.
- Qelbree is the first non-stimulant drug approved for treating ADHD in adults in 20 years.
- People with ADHD take the medication once per day, and it is available in an extended-release capsule.
ADHD is a neurodevelopmental disorder that can cause hyperactivity and inattention. Symptoms of the disorder are often present during childhood and can continue into adulthood.
In addition to causing hyperactivity and inattention, ADHD can also cause other symptoms such as impulsivity, executive dysfunction, fidgeting, and difficulty following instructions. Symptoms can vary from person to person.
According to the Attention Deficit Disorder Association, around 11 million adults in the United States have ADHD.
When ADHD is left untreated in adults it can cause difficulty maintaining relationships, job instability, and mental health issues, such as depression and anxiety. Fortunately, there are a number of treatment options for ADHD.
Some people with ADHD utilize psychotherapy and occupational therapy for managing ADHD symptoms, while others use medications or a combination of therapy and medications.
There are both stimulant and non-stimulant options available for treating ADHD. Some stimulant medications include:
The downside to using these medications is that they are controlled substances and have the potential for misuse.
Doctors can also prescribe non-stimulant medications, but there are not many available compared to stimulant options. Some non-stimulant medications include:
Additionally, sometimes doctors prescribe antidepressants to improve ADHD symptoms.
People who are prescribed Qelbree take it once per day. As an extended-release drug, people taking it see benefits throughout the day after they titrate up to their target dose.
Qelbree contains viloxazine, which doctors prescribed for depression in the past. It is a selective norepinephrine reuptake inhibitor (SNRI).
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Dr. David Merrill shared his thoughts about Qelbree in an interview with Medical News Today and explained how Qelbree works.
“Similar to the last non-stimulant approved by the FDA for ADHD called atomoxetine, the mechanism of viloxazine also involves an increase of a neurotransmitter in the brain called norepinephrine that we know is important for attention,” Dr. Merrill explained.
Dr. Merrill is a psychiatrist and director at the Pacific Neuroscience Institute’s Pacific Brain Health Center at Providence Saint John’s Health Center in Santa Monica, CA.
“In addition, viloxazine has complex actions at serotonin receptors that may lead to additional benefits for patients using the medication for attention,” commented Dr. Merrill.
Scientists utilized the Adult ADHD Investigator Symptom Rating Scale (AISRS) to determine the severity of the ADHD symptoms the participants experienced at the beginning of the trial.
In the Phase III study of the effectiveness of Qelbree in adults, people who took Qelbree saw a reduction in their symptoms at the end of the 6-week study.
According to the clinical trial results released by the drug’s manufacturer, participants who took Qelbree saw a 41% decrease in symptoms while people who took a placebo saw a reduction of 32%.
The participants that received Qelbree also saw improvements in the inattention and hyperactivity/impulsivity AISRS subscale scores. They began seeing benefits from the medication by the beginning of the second week of the trial.
The most common side effects the participants experienced were insomnia, headaches, tiredness, and nausea.
Additionally, some participants reported suicidal thoughts, for which the medication carries a boxed warning.
Qelbree showed no potential for misuse in trials, which is one of the biggest concerns with other ADHD medications.
“We are proud to bring a new novel non-stimulant option for adults into the market after 2 decades,” says Jack Khattar, the president and CEO of Supernus Pharmaceuticals.
“Since current treatments for adult ADHD are limited and don’t always work, it’s promising to have another option,” said Dr. Merrill.
“Viloxazine is an old drug that has now been studied and approved for a new indication,” continued Dr. Merrill. “While it is a brand-only drug, meaning that it will be more expensive than other available treatment options for the same condition, the manufacturer is emphasizing a plan for affordable pricing.”
Professor James Brown, who works at both Psychiatry-UK and the School of Biosciences at Ashton University in England, also spoke with MNT about Qelbree.
“The addition of more effective pharmacotherapies for ADHD is welcome,” said Prof. Brown. “Long-term adherence to medication for ADHD can be as low as 12% and around 30% of patients with ADHD do not respond to the first-line medication stimulant drugs, including methylphenidate.”
Prof. Brown also noted that some adults either cannot take stimulants or do not respond well to them, which makes Qelbree an important option.
“The addition of Qelbree as a treatment option could potentially help millions of adults who cannot take current medication due to its ineffectiveness or tolerability,” commented Prof. Brown.