LANGHORNE, Pa, December 9, 2014 -- Aprecia Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for the first product using its proprietary ZipDose® technology, a groundbreaking formulation platform that enables medicine to swiftly disperse in the patient’s mouth with a sip of water or other liquid. ZipDose products enable people to take their medications with greater ease, potentially increasing adherence and improving symptom management.
ZipDose products satisfy an unmet patient need by achieving dosage strengths that are commercially unattainable using current fast-melt technologies (orally disintegrating tablets and oral thin films). Additionally, ZipDose products are more portable than liquid formulations and have greater dosing accuracy than liquids, which are susceptible to measurement errors.
“The FDA’s acceptance of our filing is an important milestone for Aprecia as we seek FDA approval for our first product based on the ZipDose technology platform,” said Don Wetherhold, Chief Executive Officer. “This is the first in a line of products in the CNS therapeutic area that Aprecia plans to introduce over the next several years as part of our commitment to transform and improve the experience of taking potentially lifesaving medications.”
Aprecia develops its ZipDose formulations using a combination of expertise in formulation science and the layer-by-layer manufacturing capabilities of its proprietary Three-Dimensional Printing (3DP) system. Aprecia built its ZipDose platform using 3DP technology that originated at Massachusetts Institute of Technology (M.I.T.). Using the 3DP technology as a catalyst, Aprecia created a novel manufacturing system to produce fast-melt formulations of medicines that exceed the disintegration speed and dose-load capacity of products made by other fast-melt technologies. Aprecia holds an exclusive, worldwide license from M.I.T. for pharmaceutical applications of the 3DP technology.
Aprecia is a specialty pharmaceutical company that uses proprietary ZipDose technology to transform the way people take medicine. Aprecia is the first and only company in the world to utilize Three-Dimensional Printing (3DP) technology to develop and manufacture pharmaceutical products at commercial scale. Aprecia plans to introduce multiple new ZipDose products in the coming years, focusing first on the CNS therapeutic area, where there is a need for medicines that are easier to take. For more information visit http://www.aprecia.com.