Alkermes Says Experimental Drug Could Open New Path in ADHD Treatment

Alkermes plc (NASDAQ:ALKS) on Monday released topline results Monday from its Phase 1 proof-of-concept study evaluating ALKS 7290, an investigational orexin 2 receptor agonist designed to treat attention-deficit hyperactivity disorder (ADHD) in adults.

The trial provided the first clinical evidence of an orexin receptor agonist treating ADHD symptoms.

The study evaluated 88 healthy volunteers and 50 adults with ADHD, demonstrating that ALKS 7290 was generally well tolerated across all tested doses.

Promising Clinical Improvements

In the Phase 1b trial segment, 50 adult participants completed a two-week washout of prior medications before receiving daily split doses of 20 mg or 50 mg of ALKS 7290, or a placebo, for 14 days of inpatient treatment.

At day 14, participants receiving ALKS 7290 achieved dose-dependent reductions from baseline on the Adult ADHD Investigator Symptom Rating Scale.

Patients recorded median total score reductions of 14.0 points in the 20 mg group and 19.0 points in the 50 mg group, with improvements appearing as early as day 6 across both inattentive and hyperactivity subscales.

ALKS 7290 also improved overall disease severity on the Clinical Global Impression-Severity Scale.

Median scores decreased by 1.0 point for the 20 mg group and 2.0 points for the 50 mg group, shifting overall severity from markedly or moderately ill to mildly ill.

EEG-based biomarkers and cognitive assessments showed treatment effects in working memory, attention, processing speed, and information processing.

Alkermes said ALKS 7290, an investigational oral orexin 2 receptor agonist, could offer a novel approach to ADHD by targeting a brain pathway involved in wakefulness, attention, cognition and mood.

Safety Profile And Next Steps

The investigational drug maintained a favorable safety profile with no serious treatment-emergent adverse events reported.

The most common adverse events were mild and included insomnia, pollakiuria, dizziness, altered sustained attention, micturition urgency, and constipation.

No participants receiving ALKS 7290 discontinued the trial, while two placebo participants dropped out.

Alkermes is currently enrolling approximately 312 adults with ADHD for a Phase 2 study evaluating once-daily and split doses over four weeks. Investigators dosed the first participant in September 2026.

ALKS Price Action: Alkermes shares were up 1.27% to $43.95 at the time of publication on Monday, according to Benzinga Pro data.

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