An estimated 129 million individuals aged five to 19, along with 366 million adults globally, are affected by ADHD. Credit: MGARCIA_CREATIVE/Shutterstock.

Tris Pharma has received additional ex-US approvals for its attention deficit hyperactivity disorder (ADHD) treatments, Quillivant XR and QuilliChew ER.

The Saudi Food and Drug Authority approved Quillivant XR Suspension and Quillivant XR prolonged-release tablets, in October 2024, to treat patients aged six years and above.

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China’s National Medical Products Administration has also approved the usage of Quillivant XR as methylphenidate hydrochloride for sustained-release suspension and QuilliChew ER as methylphenidate hydrochloride extended-release chewable tablets to treat ADHD, and Israel’s Ministry of Health Pharmaceutical Division approved Quillivant XR in early 2024.

The company is actively pursuing distribution partnerships to increase its accessibility in Israel.

These developments follow Health Canada’s 2023 authorisation of the use of Quillivant ER and Quillivant ER for treating the condition in children between the ages of six and 12.

Manufactured in the US, the therapies are currently available in several countries following approvals.

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Quillivant XR is known for its rapid onset of action, which can be as soon as 45 minutes, and allows for personalised dosing. The QuilliChew ER tablets offer flexibility with scored tablets suitable for paediatric patients.

Both therapies leverage the company’s LiquiXR technology.

An estimated 129 million individuals aged five to 19, along with 366 million adults globally, are affected by ADHD.

Tris Pharma CEO and founder Ketan Mehta stated: “These additional Quillivant and QuilliChew regulatory approvals are a testament to the growing global recognition that patients could benefit from long-acting ADHD therapies that can be tailored to their individual needs.

“As the population of people diagnosed with ADHD rises and many countries continue to experience medication shortages, we’re proud to expand the availability of products from our robust ADHD portfolio to potentially support millions of people worldwide living with ADHD.”