Alkermes Just Dropped the First ADHD Data for a New Class of Drugs — and It Could Be a Game-Changer
Alkermes Just Dropped the First ADHD Data for a New Class of Drugs — and It Could Be a Game-Changer
What if the next big breakthrough in ADHD treatment didn’t come from a stimulant, or even from a traditional psychiatric drug at all? What if it came from a molecule that mimics a brain protein most of us have never heard of — one that regulates wakefulness, arousal, and alertness?
That’s exactly what Alkermes is betting on. And the first human data, released today, suggests the bet might pay off.
The Data That Has Everyone Talking
Alkermes, a neuro-focused biotech, shared results from a small phase 1b trial of 50 adults with ADHD. Patients received either a placebo or ALKS 7290, an orexin agonist, at doses of 20 mg or 50 mg. After just two weeks, the results were striking: scores on the 54-point Adult ADHD Investigator Symptom Rating Scale dropped by an average of 14 points in the 20 mg group and 19 points in the 50 mg group. On the Clinical Global Impressions Scale, a seven-point measure of disease severity, patients in the 20 mg and 50 mg groups moved from baseline scores of four and five down to averages of one and two, respectively.
That’s not a subtle shift. That’s a meaningful change in how patients experience their symptoms.
“We’re the first to move this new class into other diseases,” Alkermes CEO Blair Jackson told Fierce. “We were incredibly happy to see, across a number of different metrics, that the drug performed quite well, and it gives us a lot of things to think about as we design the program moving forward.”
To be clear, the trial wasn’t designed to statistically prove efficacy. It’s early days. But the signal is strong enough to warrant serious attention.
Why Orexin Matters
Orexin is a brain protein that regulates arousal and alertness. You’ve probably heard of it in the context of sleep disorders — Takeda’s Orzeyful recently became the first approved orexin agonist, for narcolepsy. But Alkermes is asking a different question: if orexin can keep you awake, can it also sharpen the neural networks that govern attention and impulse control?
The early answer appears to be yes.
“The first-in-human data provide early evidence supporting the potential of the orexin pathway to influence the brain’s neural networks that are linked to ADHD,” said Dr. Greg Mattingly, a psychiatrist at St. Charles Psychiatric Associates and Washington University School of Medicine, in a release from the company.
That’s a big deal. ADHD treatments have largely relied on stimulants and a handful of non-stimulants, all with their own limitations and side effects. A new mechanism of action — one that works through the brain’s arousal system rather than directly on dopamine or norepinephrine — opens up entirely new possibilities.
Safety and Next Steps
No new safety signals emerged in the trial, according to Jackson. The most common side effects were dizziness, constipation, changes in sustained attention, and more frequent and urgent urination. That last one is a known side effect of orexin agonists, so it’s not surprising.
Alkermes isn’t wasting time. A phase 2 trial is already enrolling, testing three dosing paradigms over four weeks — a longer window that better reflects real-world ADHD treatment. Once more safety data is gathered in adults, the company plans to move into pediatric trials.
That’s important, because ADHD is most commonly diagnosed in children. And diagnosis rates have been climbing for years, in both kids and adults.
“When you think of these children, ADHD tends to hit them at a very vulnerable stage,” Jackson said. “They lose their confidence, and they’re pegged as problem children.”
That’s a human way of framing what is also a massive market opportunity. The CEO called ALKS 7290 a potential “company changer” for Alkermes — especially when considered alongside its lead orexin agonist for sleep disorders, alixorexton.
The Bigger Picture
Alkermes already has a solid commercial portfolio, including the antipsychotic Aristada for schizophrenia and Lumryz for narcolepsy. But as Jackson candidly admitted, “Alkermes has a bunch of great products for mental health and addiction, and they generate a lot of money for us, but we’ve never had a blockbuster.”
That could change. Orexin agonists have been branded the “GLP-1s of neuroscience” — a nod to the transformative weight-loss drugs that reshaped entire markets. If ALKS 7290 works in ADHD, and alixorexton works in narcolepsy and idiopathic hypersomnia, Alkermes could find itself at the center of a new treatment paradigm.
And it’s not just ADHD and sleep. Another orexin agonist, ALKS 4510, is in phase 1 development for fatigue associated with multiple sclerosis and Parkinson’s disease. The potential applications keep expanding.
What This Means for Patients
For now, the data is early. Phase 1b trials are small, and the results, while promising, aren’t definitive. But they’re a signal — a strong one — that the orexin pathway might do more than just keep people awake. It might help them focus, regulate their emotions, and function better in daily life.
For the millions of people living with ADHD, that’s a reason to pay attention. Not because a new drug is around the corner — it isn’t — but because the science is moving in a genuinely new direction.
Alkermes is still years away from potential approval. Phase 2, then phase 3, then regulatory review. But the company is moving fast, and the early data suggests it has something real.
The question now isn’t whether orexin agonists will change neuroscience. It’s how far that change will reach — and who will benefit first.
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Mike Brown
Mike Brown – One of those authors who helps readers not get lost in today's news flow. He dives into political affairs as well as world events, social trends, and everyday stories that matter to everyone. The main focus of his work is fact-checking, clear language, and the ability to lay out the key points so that the reader gets a comprehensive and reliable picture of the topic in just a few minutes.
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