FDA greenlights Espero’s Gonitro for angina patients

Gonitro
FDA approves Espero's Gonitro.

The FDA has given its okay to Espero Pharmaceutical’s Gonitro that is indicated to provide or prevent acute relief to patients who suffer an attack of angina pectoris.

The nitroglycerin sublingual powder, which comes in single-dose packets, is for patients who feel they are about to or have had an attack due to coronary artery disease. The packets contain short-acting nitrate in a stabilized crystal granule form, the company said.

The company is touting Gonitro as the first new dosage form in the short-acting nitrate category in nearly 20 years.

“Short-acting nitrates are the current standard of care for acute relief of an angina attack,” Dr. A. Allen Seals, Fellow of the American College of Cardiology, said in a statement “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 U.S. under a licensing agreement with Pohl Boskamp. The company expects Gonitro to be available in the second half of 2016. 

Two years ago there was a shortage of nitroglycerin when manufacturing problems sidelined supplies from Hospira ($HSP) and American Regent. Baxter ($BAX) also had to recall a lot of nitroglycerin in 5% dextrose when particulate was found in a vial.

- here’s the release

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