The FDA has approved the world’s first 3D printed drug – Aprecia’s Spritam for the treatment of epilepsy.
3D printing allows Sprtiam (levetiracetam) to be made more precisely and therefore pack a higher dosage into a smaller tablet – up to 1,000mg – which dissolves quickly and is easy to administer. As each drug will be completely uniform, it also means doses are more consistent.
“By combining 3D printing technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience,” said Don Wetherhold, chief executive officer of Aprecia.
“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.”
Although the FDA has previously approved 3D-printed medical devices, this is the first time a 3D-printed product has been approved for use inside the human body.
Commenting on the news, David Emm, Principal Security Researcher at Kaspersky Lab, says: “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 down side.
“We have already seen news stories highlighting potentially contentious issues surrounding 3D printing. As it becomes more widely available, there’s the possibility of it being exploited to create harmful things. It’s likely to be just as true in the area of drugs. This technology is obviously designed to help produce specific drug dosages and combinations, but in doing so, it also makes the technology available to those with malicious intent. Currently drugs are manufactured in specially designed locations with rigorous controls and regulations. However, if the devices used to do this in the future have Internet connectivity, it raise the possibility of attackers altering the formulation of the drugs being printed to cause harm to those taking them.
“The internet of things, as we tend to call todays multitude of connected devices, has made our lives a lot easier and a lot more streamlined. However, it is not without its potential pitfalls, and this case highlights that where connected devices have a direct impact on our health and safety, stringent controls and checks must be applied, in order to prevent malicious or accidental tampering.”
Aprecia, though, says there is little to worry about when it comes to its drug: "Spritam has been designed to deliver specific dosage strengths commonly prescribed to treat epilepsy (250 mg, 500 mg, 750 mg, and 1000 mg). It is manufactured in an FDA-inspected and approved facility in keeping with the Agency’s current Good Manufacturing Practices. In addition, our manufacturing process is not dependent on internet connectivity."
Spritam is expected to be available in the first quarter of 2016.