First 3D-printed drug approved by FDA
pharmafile | August 4, 2015 | News story | Manufacturing and Production, Research and Development | 3d printing, FDA, manufacturing, production
The world of medicine saw a new pharma milestone this week, with the first approval by the FDA of a 3D-printed drug for medical use.
3D-printed (3DP) medical products, including prosthetics, have previously been approved by the administration, but Aprecia’s epilepsy treatment Spritam (levetiracetam) is the first to get the nod for use in the human body.
The product, which is expected to launch in Q1 2016, was created using Aprecia’s ZipDose technology, which prints in layers to produce a highly porous formulation that rapidly disintegrates when taken with just a sip of liquid, potentially helping people with swallowing disorders.
This allows Spritam to be used by patients prescribed high dosages, as the drug can be absorbed into the blood stream in as little as 10 seconds.
Nearly three million people in the United States have been diagnosed with active epilepsy, with an estimated 460,000 of those cases occurring in children.
Aprecia’s chief executive Don Wetherhold, says: “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.”
The Ohio-based company says its printing system can create individual tablets with drug doses of up to 1,000 milligrams, and that it plans to develop other medications using ZipDose in the coming years.
While we remain many years away from the 3D printing of replacement organs and body parts, Spritam’s approval is an important step in demonstrating the safety of 3DP products in the human body and may pave the way to reaching these goals.
Joel Levy
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