Tris Pharma gets international approvals for ADHD treatments

Tris Pharma has achieved significant milestones with its ADHD treatments, Quillivant XR and QuilliChew ER, obtaining new international approvals. The Saudi Food and Drug Authority granted approval for Quillivant XR Suspension and prolonged-release tablets in October 2024, authorizing their use for individuals aged six and older.

In addition, the National Medical Products Administration of China approved Quillivant XR in the form of methylphenidate hydrochloride sustained-release suspension, as well as QuilliChew ER as methylphenidate hydrochloride extended-release chewable tablets for ADHD treatment. Israel's Ministry of Health Pharmaceutical Division also greenlit Quillivant XR in early 2024. Tris Pharma is now seeking distribution partnerships to enhance accessibility in Israel.

These international approvals come after Health Canada’s 2023 authorization for the use of Quillivant ER and QuilliChew ER for treating children aged six to 12 with ADHD. Manufactured in the United States, these therapies have gained approval in several countries and are already available internationally.

Quillivant XR is noted for its rapid onset of action, which can begin in as little as 45 minutes, and it offers personalized dosing options. The QuilliChew ER tablets provide flexibility with scored tablets, making them suitable for pediatric patients. Both treatments utilize Tris Pharma’s LiquiXR technology.

Globally, ADHD affects an estimated 129 million individuals aged five to 19, along with 366 million adults. Tris Pharma’s CEO and founder, Ketan Mehta, commented on the recent approvals, emphasizing the growing global recognition of the benefits provided by long-acting ADHD therapies that can be tailored to individual needs. He highlighted that as the number of ADHD diagnoses increases and many countries face medication shortages, Tris Pharma is dedicated to expanding the availability of its comprehensive ADHD portfolio to support millions of people worldwide living with the condition.