FOCUS Trial Results Show Solriamfetol Significantly Reduces ADHD Symptoms, Severity in Adults
Solriamfetol achieved the primary and key secondary endpoint of the Phase III FOCUS trial by significantly lowering attention-deficit hyperactivity disorder symptoms and disease severity in adults compared to placebo, with a favorable safety and tolerability profile.
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Findings from the Phase III FOCUS trial (NCT05972044) show solriamfetol produced a significant reduction in the symptoms and severity of attention-deficit hyperactivity disorder (ADHD) in adult patients compared to placebo.1,2 Further, the medication was found to have a favorable safety and tolerability profile, positioning the medication as an effective new treatment for ADHD.
“ADHD substantially impairs social, academic, and occupational functioning, while negatively impacting patient quality of life and increasing the risk of morbidity and mortality,” Gregory Mattingly, MD, associate clinical professor of Psychiatry at the Washington University School of Medicine and president of the American Professional Society for ADHD and Related Disorders, said in a press release. “The results of the FOCUS trial demonstrate that solriamfetol was able to reduce mean ADHD symptom burden by nearly fifty percent, which contributed to significant reductions in disease severity. These results are especially promising as part of a comprehensive wellness plan for individuals with ADHD. The symptom improvements observed with solriamfetol were accompanied by a favorable safety and tolerability profile. Based on these compelling data, solriamfetol has the potential to be an important new treatment option for adult patients living with ADHD.”1
Under the brand name Sunosi, solriamfetol became the first and only dopamine-norepinephrine reuptake inhibitor approved by the FDA to improve wakefulness in adults with excessive daytime sleepiness associated with obstructive sleep apnea. In 2022, manufacturer Jazz Pharmaceuticals entered into a definitive agreement to divest the medication to Axsome Therapeutics.3 In addition to ADHD, the drug is also in development to treat major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder.
Trial Design
The randomized, double-blind, placebo-controlled, multicenter, six-week, parallel group FOCUS trial analyzed the efficacy and safety of solriamfetol in 516 adults with a primary diagnosis of ADHD. Patients were randomly assigned in a 1:1:1 ratio to receive solriamfetol at a dose of either 150 mg or 300 mg, or placebo, once daily for six weeks. The trial’s primary endpoint was change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at week six. At baseline, mean AISRS total scores for patients in the solriamfetol 150 mg, solriamfetol 300 mg, and placebo cohorts were 39.1, 38.3, and 37.9 respectively. The trial’s key secondary endpoint was change from baseline in Clinical Global Impression of Severity (CGI-S) for ADHD at week six.
Solriamfetol achieved the trial’s primary endpoint with a statistically significant decrease in AISRS total score, producing mean reductions from baseline of 17.7 points in the solriamfetol 150 mg cohort compared to 14.3 points in the placebo cohort (p=0.039). This translates to a 45% mean decrease from baseline in the symptoms of ADHD. At week six, a clinical response was achieved by 53.5% of patients in the solriamfetol 150 mg cohort compared to 41.3% in the placebo cohort (p=0.024). Findings for the 300 mg dose were not statistically significant for the primary endpoint.
Solriamfetol also achieved the trial’s key secondary endpoint with a statistically significantly reduction in overall ADHD disease severity compared to placebo at week six, as assessed by CGI-S for ADHD (p=0.017). Results for the 300 mg solriamfetol dose were also not found to be statistically significant for the secondary endpoint. In terms of safety, adverse events (AEs) for solriamfetol were consistent with its established safety profile and were dose-dependent, with no serious AEs reported.
“We are pleased with the positive results of the FOCUS trial which provide the first evidence from a multicenter controlled trial of the efficacy of solriamfetol in the treatment of ADHD,” Axsome CEO Herriot Tabuteau, MD, said in the release. “ADHD is a serious, heterogenous, and prevalent condition. We look forward to advancing the development of solriamfetol as a new, differentiated potential treatment for the millions of patients living ADHD. With these results in the adult population in hand, we plan to initiate a trial in pediatric patients this year.”1
References
1. Axsome Therapeutics Announces FOCUS Phase 3 Trial of Solriamfetol in Adults with Attention Deficit Hyperactivity Disorder (ADHD) Achieves Primary Endpoint. Axsome Therapeutics. News release. March 25, 2025. Accessed March 26, 2025. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-focus-phase-3-trial-solriamfetol
2. A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS). ClinicalTrials.gov. Updated April 26, 2024. Accessed March 26, 2025. https://clinicaltrials.gov/study/NCT05972044?cond=NCT05972044%20&rank=1
3. Jazz Pharmaceuticals Announces Agreement to Divest Sunosi® (solriamfetol) to Axsome Therapeutics. News release. Jazz Pharmaceuticals. March 28, 2022. Accessed March 26, 2025. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-agreement-divest-sunosir
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