Alkermes Reports Early ADHD Gains From Experimental Pill
Alkermes Reports Early ADHD Gains From Experimental Pill
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Key Points
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Participants underwent a two-week medication washout period before receiving ALKS 7290 or placebo for 14 days.
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On the Clinical Global Impression-Severity Scale, median scores improved by 1 point at 20 mg and 2 points at 50 mg; participants in the respective groups moved from baseline scores of four and five to scores of one and two.
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The trial’s 50 participants had median baseline AISRS scores of about 39, indicating moderate-to-severe ADHD symptoms; the 50-mg group’s 19-point reduction brought average symptom severity into the mild range, according to STAT News.
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Alkermes described the findings as the first clinical evidence of an orexin receptor agonist’s effects in ADHD. CEO Blair Jackson said the company was “the first to move this new class into other diseases,” while psychiatrist Greg Mattingly said the results offered early evidence that the orexin pathway may influence neural networks linked to ADHD.
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No participants receiving ALKS 7290 discontinued the study, whereas two participants in the placebo group discontinued.
Alkermes reported encouraging early results from its experimental ADHD pill, ALKS 7290, marking the first time a drug targeting the orexin pathway has shown clinical benefit in the condition. In a two-week study of 50 adults, the medication reduced ADHD symptom scores by 14 to 19 points depending on dosage, with the highest dose pushing symptom severity from moderate-to-severe into the mild range Kalkinemedia. The company is now advancing to a larger phase 2 trial with results expected in 2027.
ALKS 7290 was generally well tolerated with mostly mild side effects like insomnia and dizziness Benzinga. No participants on the drug dropped out of the study, compared to two in the placebo group, suggesting the medication was acceptable to patients during this early testing phase.
A New Drug Class for ADHD Emerges
ALKS 7290 belongs to a novel class called orexin 2 receptor agonists. These drugs target the orexin pathway, a brain system that regulates alertness and attention Kalkinemedia. Psychiatrist Greg Mattingly noted the results offered early evidence that this pathway may influence neural networks linked to ADHD, opening a new treatment direction for the disorder.
Symptom Reductions Show Dose-Dependent Improvement
In the randomized, double-blind trial, participants receiving 20 mg daily saw median ADHD symptom scores drop by 14 points on the 54-point Adult ADHD Investigator Symptom Rating Scale Kalkinemedia. Those on 50 mg achieved a 19-point reduction, bringing average symptom severity into the mild range from moderate-to-severe at baseline Kalkinemedia. On a separate clinical impression scale, scores improved by 1 point at 20 mg and 2 points at 50 mg, moving participants from moderate-to-severe baseline ratings to mild or better Kalkinemedia.
Safety Profile Shows Mostly Mild Side Effects
The most common side effects were insomnia, dizziness, constipation, and urinary frequency or urgency Benzinga. All reported effects were mild in severity, and no serious treatment-related adverse events occurred during the two-week dosing period. The fact that no participants discontinued due to safety concerns suggests the drug is manageable for patients.
Path Forward: Phase 2 Testing Begins
Alkermes has begun enrolling roughly 312 adults in a phase 2 study to confirm these early findings Kalkinemedia. CEO Blair Jackson called the company the first to move this new orexin agonist class into diseases beyond its original use, positioning ALKS 7290 as a potential 'company changer' Benzinga. Full results from phase 2 testing are expected in 2027, marking the next major milestone for the experimental treatment.
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