FDA Approval for First 3D Printed Drug – Update: SPRITAM Now Available

The U.S. Food and Drug Administration (FDA) approved the first 3D printed drug product, developed and produced by Aprecia Pharmaceuticals.

August 4, 2015: SPRITAM levetiracetam is a drug prescribed in the treatment of patients suffering from epilepsy. Using their proprietary ZipDose Technology platform, Aprecia is able to 3D print tablets with a high drug load of up to 1,000 mg in a single dose, which rapidly disintegrate with just a sip of liquid. Especially children and seniors, as well as people with swallowing disorders can benefit from this form of medication.

Aprecia’s CEO Don Wetherhold explained in a press release published yesterday: “By combining 3DP technology with a highly-prescribed epilepsy treatment, SPRITAM is designed to fill a need for patients who struggle with their current medication experience. This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication.”

Following video demonstrates the rapid disintegration of SPRITAM:

Their ZipDose platform is based on a 3D printing technology developed by the Massachusetts Institute of Technology (MIT), where multiple layers of a pharmaceutical compound powder are fused together using an aqueous binding fluid.

While SPRITAM is expected to be available in the first quarter of 2016, scientists are focussing their research on personalised medication, that could eventually be 3D printed by patients at home using their desktop 3D printer.

March 23, 2016: SPRITAM tables now available

Aprecia Pharmaceuticals announced that their 3D printed SPRITAM tablets are now available as an adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures.

As it disintegrates in the mouth with a sip of liquid, it offers a new option for patients struggling to take their medication. Don Wetherhold, CEO of Aprecia, explains: “As we explored potential applications for our 3D printing technology in prescription drug products, it was important that we identified disease areas with a real need for patient-friendly forms of medication. SPRITAM is designed to transform what it is like to take epilepsy medication, and is the first in a line of products we are developing to provide patients and their caregivers with additional treatment options.”