US FDA approves first 3D-printed drug

An epilepsy treatment developed by Aprecia Pharmaceuticals has become the first drug made using 3D printing to be approved for marketing.

The new drug – called Spritam (levetiracetam) – is a generic treatment for partial-onset seizures, myoclonic seizures, and primary generalised tonic-clonic seizures in adults and children with epilepsy.

The 3D-printing technology used in its manufacture elevates it above a regular generic, however, as it allows the tablets to be made with a porous structure that disintegrates rapidly ‘with a sip of liquid’, according to Aprecia.

The company used a powder jet technology developed by Zcorp to develop its proprietary ZipDose platform, which can produce fast-dissolving tablets that can carry higher dose loads than other quick-dissolve technologies, with greater dosing precision than liquid formulations.

While the technique is already being used in the manufacture of medical devices such as prosthetics and simple implants, this is the first time a 3D-printed product has been approved for systemic use by the US FDA and is a key milestone for the technology.

The new formulation of levetiracetam is a stride forward for patients, according to Marvin Rorick, a neurologist at Riverhills Neuroscience in Cincinnati, Ohio, who said: “in my experience, patients and caregivers often have difficulty following a treatment regimen.

“Whether they are dealing with a swallowing disorder or the daily struggle of getting a child to take his or her medication, adherence can be a challenge,” he added.

3D printing is still in its infancy in the pharma industry but proponents of the technology believe it could eventually be used to tailor doses more closely to a patient and – eventually – allow for on-demand production of medicines in hospitals and clinics rather than in large, centralised factories which mainly produce compressed powder formulations.

There is also considerable interest in using 3D printing to create medicines with complex drug release profiles, as well as ‘polypills’ that can combine multiple active ingredients in a single tablet.

For example, UK researchers recently combined blood pressure drugs captopril and nifedipine with the diabetes medicine glipizide – active ingredients which would ordinarily require markedly different formulations – into 3D-printed tablets.

Spritam is scheduled for launch in the first quarter of 2016, according to Aprecia. Pricing is not yet available, and it remains to be seen whether health plans will be prepared to pay a premium for the new levetiracetam formulation, given that cheap generics are widely available.

Levetiracetam was first developed by UCB, which sells it under the Keppra brand name.

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