FDA Approves Aprecia Pharmaceuticals’ Epilepsy Drug Spritam
Aprecia Pharmaceuticals has received FDA approval for its epilepsy drug Spritam — the first using 3D technology to create a drug product.
The company’s ZipDose technology allows delivery of up to 1,000 mg of Spritam (levetiracetam) in a single tablet, which would be too large for many patients to swallow were it not for the 3D technology.
The quick disintegration is important because about 3 million people, including 460,000 children, have epilepsy and many have difficulty swallowing pills. A survey showed that 71 percent of epilepsy patients acknowledged missing taking their medicine at some time and nearly half reported suffering a seizure after missing a dose.
Spokeswoman Jennifer Zieverink says the company spent several years developing the process after licensing technology from MIT and is the first and only drugmaker to manufacture pills this way. It plans to develop similar formulas for three drugs focusing on the central nervous system.
Zieverink compares the process to an ink jet or 3D printer where the drug is created by bonding powders layer upon layer around a series of porous holes. A sip of water and those bonds disintegrate.
Spritam will be available in the first quarter of 2016. — John Bechtel