Axsome’s drug scores modest win after improving ADHD symptoms in study

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By Mariam Sunny

(Reuters) -Axsome Therapeutics’ experimental drug to treat attention deficit hyperactivity disorder (ADHD) helped improve symptoms of the developmental disorder in adults, it said on Tuesday, meeting the main goal of a late-stage study.

However, shares of the drugmaker fell nearly 6% after the drug’s modest win failed to convince investors that the drug, solriamfetol, would stand out in a crowded market that has multiple cheaper available options.

Wall Street analysts said the design of Axsome’s study made it difficult to compare the data with those for approved treatments. Axsome used a scale designed to assess symptoms in adult patients in its study, which is structured differently from the scales used in most prior studies testing ADHD drugs.

A 150-milligram dose of Axsome’s drug helped ease symptoms such as difficulty in paying attention, restlessness and impulsivity in adults as measured using a clinical scale.

But the drug failed to achieve statistically significant results at a higher dose, stoking worries about the strength of the data, according to RBC Capital Markets analysts.

Symptoms of ADHD start in childhood and often last into adulthood and are typically treated using stimulants or non-stimulant drugs.

Non-stimulants such as Axsome’s candidate and Supernus Pharmaceuticals’ approved drug Qelbree are considered less addictive than a class of treatments known as stimulants, that carry the U.S. drug regulator’s most serious “black box” warning for high abuse potential.

Rival treatments on the market such as Takeda Pharmaceutical’s Vyvanse and Teva Pharmaceutical’s Adderall are stimulants.

In Axsome’s study of 516 adults with ADHD, the 150-milligram dose of solriamfetol helped ease symptoms by 45% after six weeks of treatment, compared to a placebo.

Solriamfetol, branded as Sunosi, has already been approved in the U.S. to improve wakefulness in adults with excessive sleepiness from sleep disorders, narcolepsy and sleep apnea.

Axsome, which plans to begin another late-stage trial in pediatric patients this year, acquired solriamfetol from Jazz Pharmaceuticals in 2022.

(Reporting by Mariam Sunny and Sneha S K in Bengaluru; Editing by Sriraj Kalluvila and Shailesh Kuber)