FDA approves Espero Pharmaceuticals’ Gonitro sublingual powder

SILVER SPRING, Md. — The Food and Drug Administration has approved Espero Pharmaceuticals’ Gonitro (nitroglycerin), the company announced Tuesday. Gonitro is indicated to prevent or provide acute relief for an attack of angina pectoris due to coronary artery disease and it is available in single-dose packets of a short-acting nitrate in a stabilized crystal granule form. 

 

“Short-acting nitrates are the current standard of care for acute relief of an angina attack,” Fellow of the American College of Cardiology Dr. A. Allen Seals said. “The novel features of a sublingual powder in a portable single dose packet make Gonitro attractive to angina patients who need fast relief and want to continue to live an active lifestyle.”

 

Each Gonitro packet contains 400 mcg of nitroglycerin. Espero will promote and distribute the drug in the United States under a licensing agreement with Pohl Boskamp. The company expects Gonitro to be available in the second half of 2016.