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USFDA approves Aprecia's 3D printed drug product, Spritam to treat seizures and epilepsy

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The US Food and Drug Administration (FDA) has approved Aprecia Pharmaceuticals Company's Spritam (levetiracetam) for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy.

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Spritam utilises Aprecia’s proprietary ZipDose Technology platform  that uses three-dimensional printing (3DP). While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA. ZipDose Technology enables the delivery of a high drug load, up to 1,000 mg in a single dose. Spritam is expected to be available in the first quarter of 2016.
Spritam (levetiracetam) is a prescription medicine taken by mouth that is used with other medicines to treat primary generalised tonic-clonic seizures in people 6 years of age and older with certain types of generalised epilepsy, myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy, and partial onset seizures in people 4 years of age and older with epilepsy. Administer whole Spritam along with a sip of liquid. Spritam is recommended for use in patients weighing 20 kg (44 lbs) or more.

Nearly three million people in the United States have been diagnosed with active epilepsy, with an estimated 460,000 of those cases occurring in children. Additionally, in a recent survey of people aged 65 years and older living in an independent living facility, 15 per cent reported difficulty swallowing. Other chronic conditions can impair the ability to swallow, further exacerbating the problem.

Using 3DP as a catalyst, Aprecia is developing formulations of medicines that rapidly disintegrate with a sip of liquid, even at high dose loads. Aprecia is the first and only company in the world to utilise three-dimensional printing technology to develop and manufacture pharmaceutical products at commercial scale.  Aprecia holds an exclusive, worldwide license for pharmaceutical applications of this 3DP technology.


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