FDA approves first 3D printed pill
Designed to treat epilepsy, a new drug whose ultra-porous, 3D printed surface allows it to disintegrate instantly with a sip of water, became the first of its kind to gain approval from the US Food and Drug Administration (FDA).
Ohio-based Aprecia Pharmaceuticals Company announced this week that the drug, Spritam, has been approved for the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in children and adults living with epilepsy.
Developed at Massachusetts Institute of Technology (MIT), the delivery technology is called ZipDose and it could soon change the way we take pills.
"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," says Don Wetherhold, Chief Executive Officer of Aprecia.
What's special about a 3D-printed pill?
For starters, the fast-dissolving porous surface is a good choice for those who encounter trouble swallowing conventional pills -- often the elderly or very young children.
Yet the principal advantage of the technology is that it delivers a high drug load of up to 1,000 mg in just one dose.
Ultimately, the technology aims to promote adherence with its efficiency, which requires no measuring, and the high dosage makes it easily portable.
Citing a 2002 study, the company points out in a press release that 71 percent of patient-participants using seizure treatments acknowledged problems adhering to their medication routine, often leading to seizures.
Who could benefit?
The drug -- whose generic name is levetiracetam -- will be sold under the name Spritam and will be available by prescription starting in 2016, according to the company press release.
The minimum age for taking the medication is four, and it's recommended that patients weight at least 44 lbs (20 kg).
As with many antiepileptic drugs, side effects include sleepiness, weakness and muscle coordination trouble.
At press time, Aprecia has exclusive pharmaceutical rights to the technology.
