Recent FDA approval of the first 3D-printed drug is being hailed as a breakthrough in precision medicine – and perhaps the first step toward printing medications at home.
That's admittedly a long way off, but Ohio-based Aprecia Pharmaceuticals and Forbes are touting the Aug. 3 approval by the U.S. Food and Drug Administration of SPIRITAM as a huge step forward in the development of personalized drug therapies, and one that could help providers treat a wide range of very specific health conditions.
SPIRITAM levetiracetam is used as a prescription adjunctive therapy for partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy, according to Aprecia officials. Because epileptics often have trouble swallowing what are often large pills, or are dealing with a swallowing disorder, the ideal medication needs to be delivered in a small, highly concentrated (up to 1,000 mg) dose that dissolves quickly.
Aprecia officials noted that while many epileptics have swallowing issues, there's also a high incidence of missed doses or other medication management issues, hindering treatment for the disease. They cited one study in which 71 percent admitted forgetting, missing or skipping a does of seizure medication, and almost half reported suffering a seizure because of that missed dose.
Aprecia is manufacturing SPIRITAM with its proprietary ZipDose Technology platform, which uses three-dimensional printing (3DP) to create a "porous formulation that rapidly disintegrates with a sip of liquid." By using the 3DP platform, Aprecia can produce individual doses of the drug to exact specifications and that dissolves quicker than a normal pill.
"By combining 3DP technology with a highly-prescribed epilepsy treatment, SPIRITM is designed to fill a need for patients who struggle with their current medication experience," Don Wetherhold, Aprecia's CEO, said in a press release. The company plans to market the new drug early next year, and Wetherhold said this will be the first in a line of products designed to help people with central nervous system ailments.
Writing in Forbes, Robert J. Szczerba said this could help providers develop better medication management programs for their patients.
"3D printing of medications will allow doctors to know that the medicine they’re prescribing delivers the exact dose intended, as each pill will be completely uniform and tailored for the individual patient," he wrote. "Such a capability opens the door to a number of fascinating distribution options as well, including the eventual possibility of printing personalized medicine in one’s own home."