Jacksonville’s Espero Pharmaceuticals gets go-ahead for GONITRO

In an advance for heart health, Jacksonville, Florida’s Espero Pharmaceuticals Inc. recently received approval from the U.S. Food and Drug Administration (FDA) to market a fast-acting sublingual medication for angina caused by coronary artery disease.


In an advance for heart health, Jacksonville, Florida’s Espero Pharmaceuticals Inc. recently received approval from the U.S. Food and Drug Administration (FDA) to market a fast-acting sublingual medication for angina caused by coronary artery disease.

Dubbed GONITRO, the trademarked product comes in single-dose packets and is the first of its kind, acting as a nitrate in crystal granule, or powder, form.

"The FDA approval of GONITRO enhances the treatment options available to the more than 8 million U.S. patients suffering with stable angina due to coronary artery disease (CAD), the most common type of heart disease,” Quang Pham, Espero founder and CEO, said. “GONITRO is a sublingual nitrate and as this class of drug therapy is a Class I recommendation according to the 2012 Stable Ischemic Heart Disease (SIHD) Guidelines, it should be prescribed to all patients with known SIHD.”

The product has earned a thumbs-up from the American College of Cardiology, whose spokesperson Dr. A. Allen Seals stated that fast acting nitrates are the standard treatment for angina attacks. Moreover, he said, the single dose format is appealing to patients “who need fast relief and want to continue to live an active lifestyle.”

Each dose contains 400 micrograms of nitroglycerin. The medication was developed in response to data showing that absorption in the current sublingual form is faster than in an earlier spray product, which was also introduced by Espero and has been on the market since 1997.

“GONITRO is the first new dosage form in the short-acting nitrate category in nearly 20 years and we intend to educate health care providers and patients about our exciting new product immediately,” Jeff Cole, Espero Pharmaceuticals president and CFO, said.

 

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