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3D Printed Drugs: The First of Its Kind Approved by the FDA

Last updated Aug. 5, 2015

Approved by: Krish Tangella MD, MBA, FCAP

Aprecia Pharmaceuticals

According to Aprecia Pharmaceuticals, surveys have shown that for individuals over the age of 65, approximately 15% report difficulty in swallowing pills.

On August 3rd, 2015, Aprecia Pharmaceuticals released a statement announcing the FDA approval of the first 3D printed drug using the ZipDose ® Formulation Platform. This novel process was used to create the drug known as SPRITAM (levetiracetam), which is an oral prescription used in the treatment of seizures due to epilepsy in adults and children.

Epilepsy is a chronic brain disorder that causes seizures in children and adults. The World Health Organization estimates that virtually 50 million people suffer from epilepsy worldwide.  

According to Aprecia Pharmaceuticals, surveys have shown that for individuals over the age of 65, approximately 15% report difficulty in swallowing pills. Although there can be several circumstances that prevent a patient from taking medication as prescribed, missed doses can challenge results from treatment. Additionally, a study in 2008 demonstrated that breakthrough seizures are more likely when epilepsy patients have poor adherence to their drugs.

ZipDose ® technology allows for the manufacture of layered, rapidly disintegrating medications with just a sip of liquid at high dosages. Just one dose of the medication can administer up to 1,000 mg. The pill is layered such that the drug dosage can be controlled and custom-made for each individual.

Marvin H. Rorick III, M.D., a neurologist at Riverhills Neuroscience in Ohio, states, “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.” Dr. Rorick III goes on to mention that “having an option for patients to take their medication as prescribed is important in managing the disease.”

The release of this novel drug is not only significant in the field of emerging technology, but its future implications for more precise administration of medications has the potential to change the way prescriptions are used for the treatment of various conditions. 

SPRITAM is expected to be available on the market beginning in 2016. For further information regarding SPRITAM and its associated side effects and precautions, click here.

Primary Reference 

Zieverink, J. (2015 Aug 3). FDA Approves the First 3D Printed Drug Product. Retrieved from https://aprecia.com/pdf/2015_08_03_Spritam_FDA_Approval_Press_Release.pdf

Additional References

(2015 May). Epilepsy. Retrieved from http://www.who.int/mediacentre/factsheets/fs999/en/

Davis, K. L., Candrilli, S. D., & Edin, H. M. (2008). Prevalence and cost of nonadherence with antiepileptic drugs in an adult managed care population. Epilepsia, 49(3), 446-454. Retrieved from http://onlinelibrary.wiley.com/doi/10.1111/j.1528-1167.2007.01414.x/full

Epilepsy Fast Facts. Retrieved from http://www.cdc.gov/epilepsy/basics/fast-facts.htm

DoveMed Resources

Epilepsy. Retrieved from http://www.dovemed.com/epilepsy/

Reviewed and Approved by a member of the DoveMed Editorial Board
First uploaded: Aug. 5, 2015
Last updated: Aug. 5, 2015