FDA Approves Worlds’ First 3D-Printed Drug

In a year that has seen everything from wedding cakes to violins receiving the three dimensional-printing treatment, it was only a matter of time before the pharmaceutical industry found a use for the trendy method of manufacture.

This month, Aprecia Pharmaceuticals has claimed the title of being the first company to successfully acquire FDA approval for a drug manufactured using 3D-printing technology. The drug, SPRITAM (levetiracetam), has been licenced for use with other medicines to treat primary generalized tonic-clonic, myoclonic and partial onset seizures.

Levetiracetam is an anticonvulsant medication used to treat epilepsy that has been available in generic form since 2008. The drug works as a neuromodulator and is thought to reduce the symptoms of epilepsy by hindering the conductance of action potentials between neurones.

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Far from a hollow marketing ploy, Aprecia’s technique allows for doses as high as 1,000mg in a single, porous pill that is soluble in a sip of liquid. Aprecia has stressed the importance of this more convenient form factor for those with epilepsy who struggle to adhere to complicated medication plans or who may suffer from a concurrent swallowing disorder.

SPRITAM was developed using Aprecia’s proprietary ZipDose technology. ZipDose is based on a technique developed at the Massachusetts Institute of Technology in 1984, and Aprecia has exclusive, worldwide license for pharmaceutical applications of this 3D-printing technology at present. Aprecia has also publicly stated that they have filed patent applications to protect this proprietary manufacturing process through until 2033, clearly seeking to position themselves as the company synonymous with this manufacturing method.

Aprecia Zipdose

Don Wetherhold, the current Chief Executive Officer of Aprecia, said in the press release for SPRITAM “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.” He also stated, “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.”

SPRITAM is expected to hit the market in the first quarter of 2016.

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