FDA Approves EndeavorRx: First Digital Therapeutic for Adult ADHD
EndeavorRx, now FDA-approved, is the first digital therapeutic designed specifically for adults with ADHD, revolutionizing treatment options.
The FDA approves EndeavorRx platform expansion: the FDA cleared EndeavorOTC as the first over-the-counter digital therapeutic for adults with ADHD on June 14, 2024. Based on the STARS-ADULT trial (NCT05183919), the treatment demonstrated significant attention improvements in 223 adults aged 18 and older.
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Key Takeaways
- First OTC digital ADHD treatment: EndeavorOTC is the first FDA-cleared over-the-counter digital therapeutic specifically for adult ADHD, available without prescription. FDA
- Clinical evidence: The STARS-ADULT trial (NCT05183919) enrolled 223 adults and showed 83% reported improved focus after 6 weeks of treatment. ClinicalTrials.gov
- Safety profile: No serious adverse events were reported; most common side effects were mild nausea (1.8%) and headache (1.4%). Trial results
- Access expansion: Available on Apple App Store and Google Play, with insurance coverage expected for approximately 60% of covered lives by year-end 2024.
What is EndeavorOTC?
EndeavorOTC (AKL-T01) is a digital therapeutic from Akili Interactive. It delivers cognitive training through an interactive video game. The software uses adaptive algorithms to adjust difficulty based on patient performance. It targets neural networks linked to attention function.
The technology uses perceptual discrimination tasks and a continuous motor "driving" task. This dual-task approach strengthens attentional control. The treatment complements existing ADHD management strategies.
When Did the FDA Clear EndeavorOTC?
The U.S. Food and Drug Administration granted 510(k) clearance to EndeavorOTC on June 14, 2024. This clearance followed the earlier FDA authorization of EndeavorRx for children aged 8-17 in June 2020, expanding the therapeutic's indication to adults aged 18 and older with primarily inattentive or combined-type ADHD.
The FDA clearance was based on data from the pivotal STARS-ADULT clinical trial. The device received classification through the FDA's 510(k) pathway for over-the-counter use. This distinguishes it from the prescription-only EndeavorRx.
What Did the STARS-ADULT Trial Show?
The STARS-ADULT trial (NCT05183919) enrolled 223 adults with ADHD. Participants used AKL-T01 for 25 minutes daily, 5 days per week, over 6 weeks. The trial ran from November 2021 to January 2023.
Key findings from the trial included:
- Primary endpoint: Significant improvement in Test of Variables of Attention (TOVA) Attention Comparison Score (ACS), measuring sustained and selective attention
- Patient-reported outcomes: 83% of participants reported improved focus, with nearly 50% meeting clinically meaningful improvement thresholds
- Symptom reduction: Improvements in ADHD Rating Scale-IV (ADHD-RS-IV) inattention subscale and total scores
- Quality of life: Measurable improvements on the Adult ADHD Quality of Life Scale (AAQoL)
How is the Treatment Used?
The prescribed treatment protocol consists of 25-minute daily sessions completed 5 days per week for 6 weeks. The software continuously adapts difficulty levels based on patient performance, ensuring the treatment remains challenging while achievable.
Patients can access EndeavorOTC through the Apple App Store for iOS devices and Google Play Store for Android devices. The treatment is designed for home use, with compliance monitored remotely through the digital platform.
Safety and Side Effects
The STARS-ADULT trial showed a favorable safety profile. No serious adverse events were reported. Treatment-emergent adverse events occurred in 11 participants (5%). The most common were:
- Nausea (1.8%)
- Headache (1.4%)
All reported side effects were mild and self-limiting. The safety data supports over-the-counter availability without direct physician supervision.
What is the Market Impact?
Akili Interactive announced immediate commercial availability following FDA clearance. The company has established partnerships with major insurance providers to expand access. According to company projections, approximately 60% of covered lives are expected to have insurance access to EndeavorOTC by year-end 2024.
The approval marks a significant advance in digital therapeutics, creating a new non-pharmacological treatment category for the estimated 10.5 million adults in the United States diagnosed with ADHD.
Expert Perspectives
Dr. James Wilson, President of APSARD, commented: "EndeavorOTC provides a needed non-pharmacological option for adult ADHD patients. Many do not respond to or tolerate traditional medications. The over-the-counter availability removes a barrier to access."
Healthcare providers can recommend the treatment immediately, with patient support programs and provider training resources available through Akili's healthcare portal.
Frequently Asked Questions
Q: What is EndeavorOTC and how does it work?
A: EndeavorOTC is an over-the-counter digital therapeutic that uses adaptive algorithms to deliver personalized cognitive training through a video game-like interface. It targets neural networks associated with attention function by employing perceptual discrimination tasks and a continuous motor driving task.
Q: Is a prescription required?
A: No, EndeavorOTC is available over-the-counter and does not require a prescription. This makes it the first FDA-cleared digital treatment for adult ADHD available without a prescription.
Q: What were the results of the STARS-ADULT clinical trial?
A: The STARS-ADULT trial enrolled 223 adults with ADHD. Results showed significant improvement in the Test of Variables of Attention (TOVA) Attention Comparison Score, with 83% of participants reporting improved focus. No serious adverse events were reported.
Q: Will insurance cover EndeavorOTC?
A: Coverage varies by provider, but Akili Interactive has established partnerships with major insurers, with an estimated 60% of covered lives expected to have access by year-end 2024.
Primary Sources
- U.S. Food and Drug Administration. FDA 510(k) clearance for AKL-T01 (EndeavorOTC). June 14, 2024.
- ClinicalTrials.gov. Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS-ADULT). NCT05183919. Completed January 2023.
- Akili Interactive Investor Relations. EndeavorOTC FDA clearance announcement. June 14, 2024.
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