Tris Pharma Gains More International Approvals for ADHD Treatments Quillivant XR and QuilliChew ER

Tris Pharma, Inc., a biopharmaceutical company based in Monmouth Junction, New Jersey, has announced that its ADHD medications, Quillivant XR and QuilliChew ER, have received additional regulatory approvals outside the United States. These medications, designed for the treatment of ADHD, have been approved in several new markets, expanding their availability to patients worldwide.

In October, the Saudi Food & Drug Authority (SFDA) granted approval for Quillivant XR Suspension and Quillivant XR Prolonged-Release Tablets for use in individuals aged six and older diagnosed with ADHD. Earlier in the year, the National Medical Products Administration (NMPA) in China approved Quillivant XR as Methylphenidate Hydrochloride for Sustained-Release Suspension, also for patients aged six and above. This followed the previous approval of QuilliChew ER by the NMPA as Methylphenidate Hydrochloride Extended-Release Chewable Tablets for the same age group. Additionally, the Ministry of Health in Israel's Pharmaceutical Division approved Quillivant XR for ADHD treatment earlier this year. Tris Pharma is actively pursuing partnerships to ensure the distribution and availability of Quillivant XR in Israel.

These additional regulatory approvals extend the reach of these medications beyond Canada, where Health Canada approved Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets for children aged six to twelve last year. These products are manufactured in the United States and then exported to the respective countries where they have been approved.

Ketan Mehta, the founder and CEO of Tris Pharma, expressed pride in the growing global recognition of their ADHD therapies. He highlighted the global rise in ADHD diagnosis rates and the ongoing medication shortages in many countries, emphasizing the importance of making these treatments more widely available. Quillivant XR and QuilliChew ER offer long-acting ADHD treatment options that can be tailored to individual needs, which is particularly beneficial as the number of diagnosed individuals increases.

Quillivant XR has shown effectiveness in as early as 45 minutes and maintains its effects up to 12 hours post-dose, providing consistent symptom management throughout the day. Quillivant XR's oral suspension formulation allows for personalized dosing and easy titration. QuilliChew ER, on the other hand, comes in scored chewable tablets, ideal for pediatric patients, offering flexibility in dose administration. Both formulations were developed using Tris Pharma's proprietary LiquiXR technology.

The global rise in ADHD diagnoses is believed to be driven by increased awareness and advancements in diagnostic practices. Current estimates suggest that around 129 million children and adolescents aged 5-19, as well as over 366 million adults, have ADHD worldwide.

Tris Pharma is a privately-held biopharmaceutical company dedicated to transforming the treatment of ADHD, pain, addiction, and central nervous system disorders. The company boasts a robust portfolio of ADHD products and a promising pipeline of innovative drug candidates.