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Theresa R. Cerulli, MD, discusses the known clinical profile and evidential potential of the newest non-stimulant ADHD drug for adults.
As is standard for drugs approved by the US Food and Drug Administration (FDA) for the treatment of ADHD, viloxazine extended-release capsules (Qelbree) were approved for adult patients last week on the basis of clinical trial showing significant benefit for the 3 core features of ADHD: levels of inattention, hyperactivity and impulsivity.
But, as one expert explained, it will be much more interesting to understand the absolute benefit of this non-stimulant therapy in older patients once it has fully reached the market.
In the second segment of an interview with HCPLive, Theresa R. Cerulli, MD, a neuropsychiatrist with Beth Israel Deaconess Medical Center, discussed the overt and subtle benefits of the newest indication for viloxazine extended-release. “Some of the advantages are now being able to offer adults with ADHD a non-controlled, non-abusable substance to treat those same core symptoms of this challenging condition,” she explained.
Substance abuse history is “unfortunately not uncommon” among adult ADHD patients, Cerulli said; a newly available non-stimulant option provides more confidence to prescribers. It also relieves levels of anxiety in patients concerned with the known effects of standard stimulant therapy.
That said, Cerulli reiterated that stimulants are, have been, and will remain the first-line treatment class for ADHD.
“They’ve been around for over 50-60 years now; we have a lot of experience and they work well,” she said. “It’s just that there’s some patients who stimulants are not appropriate for, or they don’t tolerate them well, and we haven’t had much else to offer in terms of pharmacotherapy.”
Cerulli noted the pharmacologic history of base viloxazine; the agent was approved as an antidepressant in Europe years prior to becoming a regulated ADHD therapy in the US. In observing the drug’s microdialysis analyses, Cerulli said viloxazine is associated with not only increased endorphin and epinephrine levels in the pre-front cortex, but also serotonin levels—a benefit uncommon for regulated stimulant therapies.
“So it does have some interesting pharmacodynamics to it,” Cerulli said. “That’s not to say that necessarily has any role in ADHD—serotonin is not something we usually think about with ADHD. But you question, when you think mechanism of action, why something may be a better fit or not…when you’re thinking about an individual patient.”
Potential benefit of comorbidities including depression, substance abuse and tic disorders—as yet remains to be seen in real-world assessments—could be feasible with the agent. Cerulli explained it would be a greatly welcome outcome as well.
“Many of us who have been in the field for some time know that, more often than not, comorbitidites are present,” she said. “It’s only about 25% of the time you’re going to see just ADHD alone. In fact, it’s about 60% or more patients who have 2 comorbidities with their ADHD.””
Lastly, Cerulli discussed the clinical and cost benefit of patients no longer “aging out” of covered care with the non-stimulant drug—which in its extended-release form is associated with more consistent daily benefit than other options.
“We always talk about continuity of care,” she said. “When I’m talking about continuity, I’m also saying the continuity through the 24-hour period shows that this isn’t an up-down drug level. This is a steady-state, non-stimulant, pharmacokinetic-profiled medication.”