The FOCUS trial is a randomised, placebo-controlled study that aims to evaluate the safety and efficacy of solriamfetol, an investigational dopamine and norepinephrine reuptake inhibitor, in adults with ADHD.
Nearly 450 adults will be randomised at a 1:1:1 ratio to receive either a 150mg or 300mg dose of solriamfetol or placebo for six weeks.
Change in adult ADHD as assessed using Investigator Symptom Report Scale is the trial’s primary endpoint.
Solriamfetol showed its agonist activity at trace by targeting amine-associated receptor 1 and 5HT1a receptors in in-vitro studies.
ADHD is a chronic neurobiological and developmental disorder that affects an estimated 5% of children and adolescents and around 11.4 million adults in the US.
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The condition is characterised by a persistent pattern of hyperactivity or impulsivity and inattention.
Based in New York, Axsome develops and delivers novel therapies for central nervous system (CNS) conditions whose treatment options are limited.
The company aims to ‘transform’ the approach to treating CNS conditions by providing therapeutic options with novel mechanisms of action.
Last month, Axsome reported new data from the SHARP trial in subjects with excessive daytime sleepiness associated with obstructive sleep apnoea.
In the trial, solriamfetol demonstrated sustained improvement in measures of cognition across eight hours when administered once a day.
The company shared these results at the American Academy of Sleep Medicine and the Sleep Research Society conference in Indiana last month.
In August 2022, the US Food and Drug Administration (FDA) approved Axsome’s Auvelity (dextromethorphan + bupropion) for the treatment of major depressive disorder (MDD) in adults.
The approval was based on results from the Phase III clinical study GEMINI (NCT04019704), which assessed Auvelity’s safety and efficacy in patients with moderate-to-severe MDD.