3D-printed drug approved for market by US regulator for the first time

Out-Law News | 05 Aug 2015 | 3:52 pm |

A US-based pharmaceutical company has been given regulatory clearance to produce a new drug using 3D printing technology.

The US Food and Drugs Administration (FDA) approved the Spritam drug made by Aprecia Pharmaceuticals Company (Aprecia) as a treatment for seizures experienced by epilepsy sufferers, the company said.

Aprecia said it is the first time the FDA has approved a drug manufactured via 3D printing (3DP).

The core idea behind 3D Printing is that you can create an object by ‘printing’ it using a designated material and, by depositing layer on top of layer, create a 3D object. This distinguishes it from traditional subtractive manufacturing processes where raw material is cut and shaped until the desired object remains.

Aprecia said the 3D printing technology it uses helps it deliver a "high drug load" to patients and said its pills more easily dissolve with water than rival treatments.

"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,” Don Wetherhold, chief executive of Aprecia said in a statement. "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."

Life sciences expert Allistair Booth of Pinsent Masons, the law firm behind Out-Law.com, said: "This is great science and has the potential to bring about a paradigm shift in how drugs are manufactured."