World’s first 3D-printed drug approved by FDA

4 Aug

The US Food and Drug Administration have approved the first drug that has been created using 3D printing technology, according to the drug’s manufacturer Aprecia Pharmaceuticals.
SPRITAM is the first drug developed using 3D-printing technology to receive approval from the FDA.
Image credit: Aprecia pharmaceuticals

SPRITAM (levetiracetam) has been approved in the form of a dissolvable pill for the treatment of seizures among people with epilepsy.

Each year, around 150,000 people in the US are diagnosed with epilepsy. Of the 2.9 million people living with the condition, around 460,000 are children.

Epilepsy is a brain disorder characterized by the occurrence of seizures, which can last from a few seconds to a few minutes. A person is normally diagnosed with epilepsy when they have two or more seizures.

Anti-seizure medication is the most common treatment for epilepsy. When such treatment is adhered to, it is effective in around 2 out of 3 patients with the condition.

However, a 2002 study published in the journal Epilepsy and Behavior found that 71% of epilepsy patients reported forgetting, missing or skipping a dose of anti-seizure medication at some point. Almost half of these patients reported having a seizure after their missed dose.

“In my experience, patients and caregivers often have difficulty following a treatment regimen,” says Dr. Marvin H. Rorick III, a neurologist at Riverhills Neuroscience in Cincinnati, OH. “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.”

“Especially for children and seniors,” he continues, “having an option for patients to take their medication as prescribed is important to managing this disease.”

Drug may improve adherence to epilepsy treatment regimens

The Aprecia team used their ZipDose Technology to develop SPRITAM – a technique that was originally created by researchers from the Massachusetts Institute of Technology (MIT).

This technology allows the drug to be layered and tightly packed into a single pill, which dissolves instantly with just one sip of liquid, making the medication much easier to administer.

Another advantage of the drug being created in this way is that up to 1,000 mg of the medication can be loaded into one dose. In addition, the layering technology allows drug doses to be closely controlled and tailored to the need of each individual patient.

It is hoped that the Food and Drug Administration’s (FDA) approval of SPRITAM will improve medication adherence among epilepsy patients, and its creators believe it may open the door to the development of new drugs for the treatment of other neurological disorders.

Don Wetherhold, chief executive officer of Aprecia, says:

“By combining 3D-printing technology with a highly-prescribed epilepsy treatment, SPRITAM is designed to fill a need for patients who struggle with their current medication experience.

This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication.”

Aprecia say SPRITAM will be available from early next year.

This latest development represents yet another breakthrough in the medical field thanks to 3D printing. In May, Medical News Today reported on the creation of 3D-printed, growth-flexible implants that saved the lives of three babies with pediatric tracheobronchomalacia (TBM) – a condition characterized by collapse of the airways during breathing.

Written by Honor Whiteman

Copyright: Medical News Today

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