The First 3D-Printed Drug, SPRITAM, Has Been Approved By The FDA
Aprecia Pharmaceuticals Company recently announced that the U.S. Food and Drug Administration (FDA) has approved their drug product called SPRITAM, making it the first 3D-printed drug the FDA has ever approved.
The active ingredient in SPRITAM is levetiracetam. It is a tablet used as a prescription adjunctive therapy to help treat partial onset of seizures, myoclonic seizures as well as primary generalized tonic-clonic seizures in both children and adults.
What’s unique about SPRITAM is that it was developed with the aid of Aprecia’s ZipDose Technology Platform, which resulted in the creation of a porous formulation that can immediately disintegrate when you take liquid with the drug. Neurologist Marvin H. Rorick III, M.D. from the Riverhills Neuroscience in Cincinnati, Ohio believes this would be of great help, especially for patients who are dealing with a swallowing disorder.
Moreover, Aprecia’s ZipDose Technology also makes it possible for a single dose of a drug to carry as much as 1,000 mg of drug load, allowing patients to take the largest of strength of levetiracetam with just a sip of water or any other liquid. In addition, since SPRITAM is a tablet, it is easier to bring along as no measuring is needed before taking the drug.
As of the moment, there are almost three million people in the United States who have been diagnosed with active epilepsy. And from that number, as much as 460,000 are children. Interestingly, a survey conducted revealed that 71% of people admitted to have forgotten, missed or skipped their seizure medication and as a result, half of them reported suffering a seizure after the missed dose.
The dosage for SPRITAM varies, depending on whether the person is dealing with partial onset seizures, myoclonic seizures or primary generalized tonic-clonic seizures. Furthermore, Aprecia Pharmaceuticals warns people to beware of possible side effects from taking SPRITAM such as “behavioral abnormalities” and suicidal thoughts. Antiepileptic drugs reportedly cause suicidal thoughts in 1 out of every 500 people taking it.