A prominent psychiatrist has described early findings from an ADHD drug trial as “a major breakthrough,” after the treatment appeared to reduce symptoms without the risks commonly associated with standard medications.
Dr Michael Halassa, a professor of psychiatry at Virginia Tech’s Fralin Biomedical Research Institute, said the medicine could ultimately prove as transformative for ADHD as Ozempic has been in the fight against obesity.
“If the medication can address ADHD symptoms without the risks of existing drugs, it would be a true game-changer,” he said. “It’s a very exciting finding.”
Known as ALKS 7290, the experimental treatment works by activating the brain’s orexin system—a network involved in wakefulness, motivation and attention.
Medicines aimed at the orexin system are already being studied for their potential to treat several sleep-related disorders.
Researchers believe that stimulating this same pathway could help people with ADHD remain more alert, attentive and focused.
Results from the early-stage trial, released last week, suggested the pioneering drug significantly eased ADHD symptoms without triggering serious side effects.
Known as ALKS 7290, the experimental drug stimulates the brain’s orexin system, which helps regulate wakefulness, motivation and attention
After taking the once-daily medication for two weeks, patients receiving the highest dose were assessed as moving from severe ADHD to mild symptoms.
The benefits were recorded across both key areas of the disorder: inattention and hyperactivity.
Researchers also reported no troubling changes in participants’ heart rate, blood pressure or electrocardiogram readings during the study—a finding that could be particularly significant.
The apparent safety advantage may distinguish ALKS 7290 from stimulant drugs, which are currently the first-line treatment for ADHD and include familiar brands such as Ritalin and Adderall.
Although stimulants help many people manage the condition, experts warn that they are not without potential risks.
These medications raise levels of dopamine and noradrenaline in the brain—chemical messengers linked to motivation, alertness and attention.
That boost can sharpen concentration, but it may also switch on the body’s fight-or-flight response.
Consequently, stimulant treatment can elevate heart rate and blood pressure. Studies have also associated prolonged cumulative use with a greater risk of hypertension, a major contributor to heart attacks and strokes.
Dr Halassa said stimulant medications may carry psychiatric risks as well.
Research has found that stimulant drugs can increase the likelihood of psychotic symptoms among some vulnerable patients.
“It’s an issue I encounter clinically myself,” Dr Halassa said. “Many patients with serious mental illness or psychosis also have an ADHD diagnosis, and they often arrive with a prescription for a stimulant.”
“The dilemma is that giving them Adderall can make their psychosis worse. There are also reports suggesting that long-term stimulant use may trigger psychotic symptoms even in people with no previous history of psychosis.”
‘This is a real problem. And I’m always interested in medication that can be an alternative for stimulants for this reason.’
Developed by pharmaceutical company Alkermes, ALKS 7290 works in a different – and entirely novel – way to improve attention.
While stimulants increase the activity of brain chemicals involved in attention and executive control, ALKS 7290 instead targets the brain’s wakefulness system.
It is part of a new class of drugs known as orexin agonists, which scientists have been investigating as treatments for rare sleep disorders such as narcolepsy.
A landmark Government-commissioned review found earlier this year that referrals, waiting lists and recorded diagnoses of ADHD have risen sharply – particularly since the pandemic
Narcolepsy is a chronic neurological disorder that impairs the brain’s ability to control sleep and wake cycles.
But orexin also plays an important role in attention and cognition – leading scientists to investigate whether drugs targeting the system could help people with ADHD.
The latest results are the first clinical evidence that an orexin agonist could improve symptoms of the condition.
‘In general, there aren’t medications for ADHD with the same effect as stimulants that don’t have similar side effects,’ says Dr Halassa.
‘It’s still early days, but the research seems to show that this new drug can keep people awake enough to stay on task. Essentially, it’s doing what stimulants do but without the abuse potential.
‘It’s giving patients more available options to choose from.’
In the trial, 50 adults with ADHD were given either ALKS 7290 or a dummy drug for two weeks.
Those taking ALKS 7290 showed marked improvements in both inattention and hyperactivity, with the biggest benefits seen among those given the higher dose.
The drug was also generally well tolerated, with no serious side effects reported.
The most common problems included dizziness, insomnia, constipation and needing to urinate more frequently.
A larger trial involving more than 300 patients is now under way to establish whether the benefits seen in the initial study can be confirmed.
‘Orexin agonists may follow a similar path to Ozempic and other GLP-1 drugs – while originally developed for a different condition, diabetes, they’ve quickly become household names for treating obesity, and have now expanded into sleep apnoea, cardiovascular and kidney disease and even substance abuse,’ says Dr Halassa.
He added that the medication could be available within the next five years, if the success in earlier trials is repeated.
Dr Barbara Sahakian, professor of clinical neuropsychology at the University of Cambridge, also welcomed the preliminary findings.
‘It would be very useful to have non-stimulant drugs for the treatment of ADHD since not everyone with a diagnosis of ADHD is treated effectively by stimulants and some people with ADHD cannot tolerate the side effects, such as headache, stomachache, and fast or irregular heartbeats,’ she said.
‘In addition, the typical stimulants have the risk of addiction. Therefore, the initial results with ALKS 7290 are of interest, and it will be important to see the efficacy of the drug in large-scale, randomised controlled clinical trials.
‘It would be very helpful to have a wider range of pharmacological treatment options for children and adults with ADHD.’
The findings come amid soaring demand for ADHD services in Britain.
A landmark government-commissioned review found earlier this year that referrals, waiting lists and recorded diagnoses have risen sharply – particularly since the pandemic.
Yet it found that the underlying prevalence of ADHD appears to have remained far more stable, raising questions about what is driving the surge in diagnoses.
Prescriptions for ADHD medication have also soared over the past decade.
