FDA approves first 3D-printed drug
Aprecia Pharmaceuticals owns Spritam (levetiracetam), a solid oral pill to treat epileptic seizures. The drug is manufactured using a three-dimensional printer which creates a porous formulation that helps bioavailability and patient uptake, the company says.
The 3D printer lets the company create a pill with a high drug load, up to 1,000mg of levetiracetam, in a single dose.
This allows patients to take the largest strengths of the drug “with just a sip of liquid,” helping children, the elderly and people with swallowing disorders to stick to their regimen, said the company. It added, “with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on-the-go.” It is likely to hit the market in Q1 2016.
Levetiracetam is already widely prescribed for epilepsy. Aprecia said the new delivery formulation is designed to help patients who struggle with current dosage forms, and it will soon be applied to other drugs.
“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,” said CEO Don Wetherhold. The oral drug delivery market was worth over $64bn last year, according to Frost & Sullivan.
3D printing has previously been used to make medical devices and replicate organs for preclinical studies, but this is the first FDA approval of a drug product.
Aprecia’s formulation platform, which it calls ZipDose technology, is based on 3D printing licensed from the original inventors at MIT. The patent-protected technique uses liquid to stitch together several layers of powder.
Aprecia plans to use its own equipment to manufacture Spritam and other high-dose medicines that rapidly disintegrate with a small amount of liquid, and says it has exclusive rights to pharmaceutical applications of the technology.
Prasco Laboratories and its parent company, Scion Companies, have a controlling interest in Aprecia.