The breakthrough ADHD drug that can ease symptoms WITHOUT the risk of heart complications

A drug undergoing trials could ease the symptoms of ADHD without some of the heart risks that are associated with existing treatments.

The medication – ALKS 7290 – works by stimulating the brain’s orexin system, the network responsible for controlling wakefulness, motivation and attention.

Experts say it potentially heralds a new era of drugs for attention-deficit hyperactivity disorder.

Drugs that target the orexin system are being investigated as treatments for certain sleep disorders. But scientists believe stimulating the same system could also help ADHD patients stay more focused.

Early trial results, released last week, found the medication dramatically reduced symptoms without causing any serious side-effects. 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. And, crucially, researchers 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 Ritalin and Adderall. While highly effective for many, they can cause side effects such as anxiety and insomnia, as well as raising heart rate and blood pressure.

Experts say the new drug has the potential to become the ‘Ozempic of ADHD’, and could be available in as little as five years.

‘It’s a very exciting finding,’ says Dr Michael Halassa, professor of psychiatry at Virginia Tech’s Fralin Biomedical Research Institute.

‘In general, there aren’t medications for ADHD with the same effect as stimulants that don’t have similar side effects. It’s still early days, but the research seems to show that increasing orexin agonists in the brain keeps people awake enough to stay on task.

‘Essentially, it’s doing what stimulants do but without the abuse potential. It’s giving patients more options to choose from.’

The findings come amid soaring demand for ADHD services. A Government-commissioned review this year found 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. These drugs, while helpful for many with the condition, can carry risks.

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 activate the body’s fight-or-flight response.

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 stroke.

Stimulant drugs also carry psychiatric risks, says Dr Halassa, increasing the chance of psychotic symptoms in some vulnerable patients and, in rare cases, triggering them in people with no previous history of psychosis.

Developed by pharmaceutical company Alkermes, ALKS 7290 works in a different, entirely novel, way. While stimulants boost the activity of brain chemicals involved in attention and executive control, ALKS 7290 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 chronic neurological disorder that impairs the brain’s ability to control sleep and wake cycles.

The latest results are the first clinical evidence that an orexin agonist could improve symptoms of ADHD. In the trial, 50 adult patients were given 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 in those on the higher dose. It was also generally well tolerated, with no serious side effects reported.

The most common issues were dizziness, insomnia, constipation and needing to urinate more often.

Experts say while the research is at an early stage, the drug could be a gamechanger. A larger trial of more than 300 patients is now under way to establish whether the benefits can be confirmed.

‘The drug’s effectiveness will need to be shown in larger-scale trials. But if it still looks good, it could be available within the next five years,’ says Dr Halassa.

‘Orexin agonists may follow a similar path to Ozempic and other GLP-1 drugs – originally developed for a different condition, diabetes, they’ve become household names for treating obesity, and have expanded into sleep apnoea, cardiovascular and kidney disease and even substance abuse.’

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. Not everyone with a diagnosis is treated effectively by stimulants and some people with ADHD cannot tolerate the side effects,’ she says.

‘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 trials. It would be very helpful to have a wider range of pharmacological treatment options for children and adults with ADHD.’