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FDA approves world’s first 3D printed drug

Aprecia’s epilepsy treatment Spritam seen as the future of drug manufacturing

Spritam 3DP drug

The FDA has approved the first ever 3D-printed drug as experts hail a new era in drug development.

The drug Spritam (levetiracetam), from Aprecia Pharmaceuticals, has been given the green light from the US regulator as an adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.

There are already a number of treatments for the condition, but the interest from industry observers has been piqued by how Spritam (pictured) is developed.

This is because it uses Aprecia's proprietary ZipDose Technology platform that creates the treatment via a three-dimensional printing (3DP) system, which in turn produces a porous formulation that rapidly disintegrates with a sip of liquid.

The ZipDose Technology enables the delivery of a high drug load, up to 1,000mg in a single dose, with the software able to tweak doses to the individual patient.

While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.

Dr Mohamed Albed Alhnan, a lecturer in pharmaceutics at the University of Central Lancashire, told the BBC: “For the last 50 years we have manufactured tablets in factories and shipped them to hospitals and for the first time this process means we can produce tablets much closer to the patient.”

It would mean that medical institutions could adjust the dose for individual patients with just a simple tweak to the software before printing. Previously, such personalised medicine would have been extremely expensive to produce, said Dr Alhnan.

Don Wetherhold, CEO of Aprecia, said: "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."

The treatment is expected to be available in the first quarter of 2016, according to the firm.

Article by
Ben Adams

5th August 2015

From: Marketing



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