The anti-arrhythmia drug amiodarone is often prescribed for control of atrial fibrillation, but can have toxic effects upon the lungs, eyes, thyroid and liver. Emory and Georgia Tech scientists have developed a method for delivering amiodarone directly to the heart in an extended release gel to reduce off-target effects.

The results were published in Circulation: Arrhythmia and Electrophysiology.

The senior author is Rebecca Levit, MD, assistant professor of medicine (cardiology) at Emory University School of Medicine and adjunct in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory. Graduate student Jose Garcia – part of co-author Andres Garcia’s lab at Georgia Tech — and Peter Campbell, MD are the first authors.

An amiodarone-containing gel was applied to the outside of the heart by a minimally invasive procedure. After a one-time delivery, the gel could reduce the duration of atrial fibrillation and the likelihood of its development for a month in a pig model. The researchers were also able to show that amiodarone did not have toxic effects on the pigs’ lungs.

As noted in the book Off-label prescribing – Justifying unapproved medicine, amiodarone is “one of the very few drugs approved by the FDA in modern times without rigorous randomized clinical trials.” As author David Cavalla describes, amiodarone was approved in the 1980s based on clinical use in Europe for ventricular arrhythmias. It later became widely prescribed “off label” for atrial fibrillation, which the FDA has issued warnings against. It is known to persist for long periods in the body, and can turn the skin blue or gray in combination with sun exposure.

The authors write that the strategy of applying a gel outside the heart (JACC Basic to Translational paper) could be beneficial for other therapies as well, such as proteins, RNA or cells.

The research was supported by the National Heart Lung and Blood Institute (L30 HL129299), the Coulter Translation Foundation and the Georgia Research Alliance. Levit is the founder of Corami Therapeutics, which seeks to commercialize the technology. Levit and CorAmi have been working with T3 labs to test it.