FDA Approved 3D Printed Drug Available In The US
The first FDA approved 3D printed drug for epilepsy, Spritam is now available in the US (Photo credit: Aprecia Pharmaceuticals)
A continued step forward in the treatment of epilepsy and the power of 3D printing. According to the Centers for Disease Control (CDC), there were 2.4 million adults living with active epilepsy in 2013. In 2015, the U.S. Food and Drug Administration (FDA) approved Spritam, the first 3D printed prescription drug to treat partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures.
Today, Aprecia Pharmaceuticals announced the availability of Spritam for the US market. The company’s 3D printing technology, ZipDose Technology, allows the pill to disintegrate in the mouth with just a little bit of water. This also opens up an option for patients who struggle to swallow a pill.
Don Wetherhold, CEO, Aprecia said when they explored potential applications for their 3D printing technology in prescription drug products, it was important to identify disease areas that had a real need for patient-friendly forms of medication.
Aprecia’s ZipDose Technology uses formulation science combined with 3D printing to create a high-dose medication in a rapidly disintegrating form. The 3D technology was actually created at Massachusetts Institute of Technology in the 1980s as a rapid prototyping technique and then expanded into tissue engineering and pharmaceuticals from 1993 to 2003. Today, Aprecia uses this technology to improve the medication taking experience for patients.
To create the 3D printed Spritam, all the elements are assembled layer-by-layer without compression or traditional molding techniques. Thin layers of powdered medication are then repeatedly spread on top of one another, as patterns of liquid droplets are printed onto selected regions of each powder layer. Interactions between the powder and liquid bond the materials together at a microscopic level.
Aprecia recently closed a $35 million fundraising round in January 2016 led by Deerfield Management Co., with JW Asset Management participating in the private stock sale. The company holds an exclusive, worldwide license for pharmaceutical applications of this 3D printing technology.