Aprecia Pharmaceuticals has obtained approval from the US Food and Drug Administration (FDA) for its Spritam levetiracetam for oral use as a prescription adjunctive therapy to treat partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy.
Claimed to be the first 3D printed drug product, Spritam uses the firm’s ZipDose Technology platform, which applies three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid.
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3DP was previously used to manufacture medical devices and this approval marks the first time a drug product manufactured with this technology was approved by the FDA.
Aprecia Pharmaceuticals CEO Don Wetherhold 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."
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According to the firm, ZipDose Technology helps in delivering high-drug load up to 1,000mg in a single dose.
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By GlobalDataThe company has developed ZipDose Technology using the 3DP technology that developed at Massachusetts Institute of Technology (MIT).
Using 3DP as a catalyst, the firm is involved in developing formulations of medicines that rapidly disintegrate with a sip of liquid, even at high-dose loads.
Commenting on the approval, Kaspersky Lab principal security researcher David Emm said: "News that the FDA has approved the 3D printing of drugs might provoke mixed reactions. On the one hand, the new production method allows precise dosage creation, and drug combinations to be manufactured for specific cases. However, as with any new technology, there’s a possible downside."
