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Triastek Reports MED 3D Printed Pharmaceutical Product Receives IND Clearance From the US FDA

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Triastek specializing in 3D printing of drug products, announces the FDA has approved its Investigational New Drug (IND) 505(b)(2) application for its first 3D printed drug product, T19.

T 19 is indicated for the treatment of rheumatoid arthritis.

Developed in-house, Triastek has global intellectual property rights to the T19 3D printed formulation.

The novel design made possible by 3D printing allows T19 to function as a chronotherapeutic drug delivery system, targeting the circadian nature of RA symptoms.

Patients take T19 at bedtime with the tablet releasing the drug in a delayed manner such that the blood concentration peaks in the early morning hours when the symptoms of pain, joint stiffness, and dysfunction are most acute.

T19 utilizes Melt Extrusion Deposition (MEDTM) 3D printing technology to achieve three-dimensional tablet structures that allow precise control of drug release to achieve the desired target PK in the human body, with the goal of addressing these unmet needs of RA patients.

By 2025, it is predicted the global RA market will reach $30.7 billion (CAGR 4.5%), with T19’s unique chronotherapeutic delivery system providing patients with a much-needed therapeutic option.

Informa, a pharmaceutical market intelligence consulting company, suggests that T19 can capture a substantial portion of the RA market in China and the U.S after launch.

Triastek plans to apply for IND approval in China later this year, followed by applications in Japan and Europe. The New Drug Application of T19 is expected to be filed to the FDA in 2023.

Following T19, Triastek has developed 505(b)(2) product portfolio to meet specific clinical needs and improve the outcomes of drug therapy using MEDTM 3D printing technology.

 

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