A leading psychiatrist has hailed ‘a major breakthrough’ in the treatment of attention-deficit hyperactivity disorder (ADHD) – after a drug was able to ease symptoms of the condition without the risks of standard medications.
Dr Michael Halassa, professor of psychiatry at Virginia Tech’s Fralin Biomedical Research Institute, said the medication, which showed promising results in early trials this week, could be as revolutionary for ADHD as Ozempic has been for obesity.
‘If the medication can address ADHD symptoms without the risks of existing drugs it would be a true game-changer,’ he added. ‘It’s a very exciting finding.’
The medication – known as ALKS 7290 – works by stimulating the brain’s orexin system, the network responsible for controlling wakefulness, motivation and attention.
Drugs that target the orexin system are already being investigated as treatments for certain sleep disorders.
But scientists believe stimulating the same system could also help patients with ADHD stay more alert and focused.
Early trial results, released last week, found the pioneering medication dramatically reduced symptoms of the disorder without causing any serious side effects.
The medication – known as ALKS 7290 – works by stimulating the brain’s orexin system, the network responsible for controlling wakefulness, motivation and attention
After just two weeks of taking the daily drug, patients given the highest dose went from being rated as severely affected by ADHD to only mildly affected.
Improvements were seen in both inattention and hyperactivity.
Crucially, researchers also found no concerning changes in patients’ heart rate, blood pressure or heart readings during the trial.
This could prove an important advantage over stimulant medications – the current first-line drugs for ADHD, often known by brand names such as Ritalin and Adderall.
These drugs, while helpful for many people with the condition, can carry risks, say experts.
Stimulants work by increasing levels of chemicals in the brain involved in motivation and alertness, known as dopamine and noradrenaline.
Higher levels of these chemicals can improve attention – but can also activate the body’s fight-or-flight response.
As a result, the drugs can increase heart rate and blood pressure, with studies linking long-term cumulative use to a higher risk of hypertension, a leading cause of heart attacks and strokes.
Stimulant medications can also carry psychiatric risks, says Dr Halassa.
Studies have shown that stimulant drugs increase the risk of psychotic symptoms in some vulnerable patients.
‘It’s an issue I encounter clinically myself,’ says Dr Halassa. ‘Many patients who have serious mental illness or psychosis also have an ADHD diagnosis as well, and often come in with a script for a stimulant.
‘The dilemma is, if you give them Adderall you can worsen their psychosis. And there are some reports that suggest long-term stimulant use can precipitate psychotic symptoms even in those 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.
