The drug, Spritam, was developed by a company called Aprecia Pharmaceuticals, to help patients control seizures brought on by epilepsy. Spritam is expected to hit the market in the first months of 2016.
I've written before about the rise of 3-D printing in medicine and its range of potential applications. 3-D printing has been around since the 1980s, but in recent years the medical sector has found some exciting new biological applications for the technology, from prosthetic limbs to living tissue.
And 3-D printing offers new options to pharmaceutical companies. By leveraging the technology, Aprecia said it was able to make a more concentrated pill, meaning patients can access a high-strength dose in a single sip of liquid. Aprecia spokesperson Jennifer Zieverink said the 3-D printed version of the drug dissolves more easily with a sip of water.
Zieverink said the company has received calls from other pharma companies that are interested in developing their own 3-D printed drugs. She said that Aprecia has three other candidates for 3-D printing in the pipeline.
To find out how 3-D printing might transform drug development, or benefit patients, I spoke with Bonnie I. Scott, a Washington D.C.-based lawyer specializing in health and life sciences. Scott, who works for the firm Epstein Becker & Green, has been following the intersection of 3-D printing and medicine closely, and has written a series of blog posts on the topic. This interview with Scott has been edited for brevity.
Why does the FDA's opinion about 3-D printing matter?
Drug companies can't reach the market unless they get approval from the FDA. It won't reach you, the patient, unless the FDA agrees that it's safe.
Have any other 3-D printed medical applications received FDA approval?
Much of the conversation over the last couple of years has surrounded 3-D printed medical devices. The FDA has already cleared several, including knee, facial and cranial implants for reconstruction procedures, and more recently, a titanium bone tether plate for the treatment of bunions.
Do you have a sense for how the agency views 3-D printing?
Last fall, the FDA held a public workshop to discuss the technical challenges and patient safety concerns surrounding 3-D printed devices. An FDA official recently noted that the agency sees 3-D printing as a manufacturing technology that is 'not something exotic from what [it's] seen before.'
That means that the FDA views these 3-D printed devices as not significantly different to existing devices on the market. What is different is the manufacturing. Now, it seems that one of FDA’s main concerns is understanding the technology and manufacturing component.
Do you anticipate that people will start printing their own drugs and medical devices?
I think it's possible, but it's far off. The kind of trajectory it may follow is to start with the traditional manufacturing environment, then move into the pharmacy space -- the pharmacist would have a 3-D printer to combine pills, for instance -- and once the kinks are worked out it might be used at home. Of course, there would still need to be some kind of screening process and buy-in from the doctor, pharmacist and patient to make sure everyone is on the same page.
Do you see this opening the door for other drug makers?
3-D printed drugs and devices hold great promise for providing patient-specific treatments. Even though FDA has yet to solidify a regulatory stance on its evaluation of these products, innovators show no sign of slowing their development efforts.
It's interesting that a relative newcomer in the pharma space received FDA approval first. When will big pharma catch up?
In this case, it's a race to the finish line. Smaller firms can move quicker and show that 3-D printing could be cost-effective and beneficial for patients. Once it has traction, larger companies will take note.
What does this mean for the future of personalized treatment?
3-D printing has tremendous potential in the pharmaceutical industry, and the technology will likely be utilized in that space down the road.
3-D printing could allow pharmacists to adapt medication doses specifically to patient needs (such as age, race, gender) and adjust those doses as needed. It also opens the door for producing new formulations of drugs, which could be particularly helpful for patients with multiple conditions. For example, a pharmacist could make one pill with multiple active ingredients. Reducing the amount of pills a patient has to take from ten to one may significantly improve medication compliance.
It might be a useful tool for children with complex medical conditions to comply with medicine -- it could open the door for things like pills that could be modeled in the shape of a cute animal, or something else that would be easier for kids.
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