New ADHD Drug Shows Promise with Reduced Cardiovascular Risk

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New ADHD Drug Shows Promise with Reduced Cardiovascular Risk

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Alkermes plc, a biopharmaceutical company, recently announced positive topline results from a Phase 1 proof-of-concept study for its investigational drug, ALKS 7290, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The study, which included 88 healthy volunteers and 50 adults with ADHD, found that ALKS 7290 was generally well-tolerated across all tested doses.

In adults with ADHD, the drug demonstrated dose-dependent, clinically meaningful improvements in ADHD symptoms, as measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS) and the Clinical Global Impression-Severity Scale (CGI-S), by day 14 of treatment. For instance, the 50 mg dose showed a median reduction of 19.0 points on the AISRS total score from a baseline of approximately 39, indicating substantial symptom improvement. These findings, reported on September 21, 2026, represent the first clinical evidence of an orexin receptor agonist producing effects on ADHD symptoms.

Existing stimulant medications for ADHD, such as amphetamine-based (e.g., Adderall, Vyvanse) and methylphenidate-based (e.g., Ritalin, Concerta) treatments, can cause modest increases in heart rate and blood pressure, typically around five beats per minute and two to five mmHg, respectively. While these changes are generally mild for most healthy adults, concerns exist regarding long-term cardiovascular effects, including a potential increased risk of conditions like hypertension and arterial disease with prolonged use. In contrast, the Phase 1 study for ALKS 7290 reported no serious treatment-emergent adverse events and no clinically significant findings for vital signs or ECGs.

ALKS 7290 is a novel, oral orexin 2 receptor (OX2R) agonist, which means it targets the orexin system in the brain. This system is crucial for regulating wakefulness, attention, cognition, and mood, offering a different mechanism of action compared to current ADHD therapies that primarily affect catecholaminergic pathways. A Phase 2 trial assessing once-daily and split dosing of ALKS 7290 in adults with ADHD is currently enrolling, with a target of approximately 312 participants, and data is anticipated in 2027.

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