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Drug made with 3-D printer wins first FDA approval

Kimberly Adams Aug 4, 2015
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People and businesses are making all sorts of things with 3-D printers, including gadgets, toys and jewelry.

Now, add prescription drugs to that list. For the first time, the Food and Drug Administration (FDA) has given approval for a 3-D-printed epilepsy drug meant to help people control their seizures.  

The active ingredient in the SPRITAM isn’t new, but what is new is the method Aprecia Pharmaceuticals used to make it, according to the company. The company says its process for printing the drug makes the pill smaller and faster dissolving. That pleases Janice Buelow, a longtime nurse and vice president at the Epilepsy Foundation, who’s seen her patients struggle with their current medicines.

“Some people do have trouble swallowing them,” she says of the sometimes very large pills. “They take multiple medications, and it just is difficult.”

She says it can be especially hard for caregivers who have to administer medicine to children and the elderly.

Medical economist Jeff Bauer says 3-D printing will eventually change the way drugs are made and make them more tailored for individual patients. He also projects “it should dramatically reduce the costs of over-prescribing or the costs of under-prescribing.”

Some economists complain the push for customized drugs will make them more expensive. But Bauer argues the tailoring of individuals drugs, with just enough of the right medicine, will bring down costs.

David Dean, who uses 3-D-printed devices in his work with reconstructive surgeons at Ohio State University, says for this kind of technology to catch on, the machines and people making the drugs will have to prove they are consistent.

That includes things like “what the operator is doing when they are using [the machine], how much freedom do they have to change the settings, and the way they’re running it from batch to batch,” he says. 

Aprecia Pharmaceuticals says the new drug will be available next year, and the company plans to 3-D print more medicines in the future.

Correction: An earlier version of this story incorrectly identified David Dean as a surgeon.

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