Aprecia Pharmaceuticals announced on Monday the release of the first prescription drug product approved by the U.S. Food and Drug Administration (FDA) that is manufactured using 3D printing technology.
Aprecia’s epilepsy medication SPRITAM (levetiracetam) is available as an adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures.
The tablets are designed to disintegrate in the mouth with a sip of liquid, offering a new option for patients, including those who may struggle to take their medicine.
“As we explored potential applications for our 3D printing technology in prescription drug products, it was important that we identified disease areas with a real need for patient-friendly forms of medication,” Aprecia CEO Don Wetherhold said in a statement. “SPRITAM is designed to transform what it is like to take epilepsy medication, and is the first in a line of products we are developing to provide patients and their caregivers with additional treatment options.”
SPRITAM is formulated with Aprecia’s proprietary ZipDose Technology, which combines the precision of 3D printing and formulation science to produce medicines that rapidly disintegrate within seconds. The technology was developed to give healthcare providers the option of offering oral formulations of highly prescribed high-dose medications that are solid, yet easy to take; easy to administer; and precisely dosed, Aprecia explained on its website.
SPRITAM is available in four unit-dose strengths: 250 milligrams (mh), 500 mg, 750 mg and 1,000 mg.