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Vital Signs The Analyst's Perspective - August 2015 Issue

Vital Signs The Analyst's Perspective - August 2015 Issue

FDA Clears First 3D Printed Prescription Drug

Source: San Francisco Chronicle, August 3, 2015; Aprecia Pharmaceuticals, August 3, 2015

On August 3, 2015, Aprecia Pharmaceuticals Company announced that the US Food and Drug Administration (FDA) approved SPRITAM (levetiracetam) for oral use as a prescription adjunctive therapy for the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in adults and children with epilepsy. SPRITAM is formulated using Aprecia’s proprietary ZipDose technology, which uses a 3D printer to produce porous tablets that quickly disintegrate with a small sip of liquid.

The Analyst’s Perspective by Barbara Gilmore, Senior Industry Analyst, Life Sciences, North America

The development of innovative orally disintegrating tablet (ODT) form drugs is nothing new. However, the methods by which the oral drugs can be prepared or formulated are new. Technological advances in the 21st century facilitate the ability to make drug products with 3D printers. Aprecia Pharmaceutical’s ZipDose technology, facilitated by its 2014 partnership with InVentiv Health, enables the commercialization of ODTs using this unique technology.

Oral drug delivery still has serious unsolved challenges. Patient groups who have difficulty swallowing capsules or tablets benefit greatly from ODT formulations. Medications that are fast-acting (e.g., for pain, diarrhea, migraines, or insomnia), require compliance (e.g., for Alzheimer’s, psychosis, schizophrenia, or hypertension), or for pediatric patients (e.g., cold, pain, ADHA) are common uses for ODT medications.

The first ODTs to be developed dissolved in the mouth, but did not taste good or had lots of chalky filler in them. As drug formulation technology improved, the pills have become less bulky. Taste has continued to be a problem for bitter chemical drugs. Micro-encapsulation, spray drying, or adding coatings have allowed the medications to be absorbed lower in the GI tract in a more delayed fashion, avoiding the bad taste.

In December 2014, Aprecia Pharmaceuticals filed a New Drug Application (NDA) with the FDA for its ZipDose SPRITAM (levetiracetam), a drug indicated for the treatment of seizures in epilepsy patients years or older. Levetiracetam has been on the market for years and is sold as an extended release oral generic by over generic companies. Aprecia Pharmaceutical benefited from the fact that levetiracetam has been on the market for a while, so the safety and efficacy of its use was not an issue. Aprecia’s ZipDose formulation is new. The FDA’s Drug Advisory Committee unanimously recommended its approval in June 2015 and SPRITAM was approved nine weeks later. Companies wishing to develop new technologies like Aprecia’s will have to follow the FDA’s drug approval process, as with any drug. If the formulation is new and the drug has been deemed safe through years of previous use, the challenges will likely be markedly less.

Aprecia Pharmaceutical’s ZipDose technology has a very promising future. The ODT market is estimated to be worth $ billion in 2015. Aprecia Pharmaceuticals has three additional CNS-directed proprietary products in its pipeline. The ZipDose is an ideal technology for drugs that need to be absorbed quickly and can be put in tablet form.

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