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news.The US Food and Drug Administration (FDA) has approved Espero Pharmaceuticals’ Gonitro (nitroglycerin) sublingual powder, which is indicated to provide acute relief for an attack of angina pectoris due to coronary artery disease.
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Gonitro is available in single-dose packets of a short-acting nitrate in a stabilized crystal granule form.
Each Gonitro packet contains 400 mcg of nitroglycerin. The clinical data suggests that the sublingual absorption of nitroglycerin is higher after the administration of Gonitro compared to Nitrolingual Pumpspray (nitroglycerin lingual spray).
Espero will promote and distribute Gonitro nitroglycerin sublingual powder in the US market under a licensing agreement with G. Pohl-Boskamp.
The product is expected to be launched in the second half of this year.
Espero Pharmaceuticals founder and CEO Quang Pham said: "The FDA’s 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.
"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 company said Gonitro should be administered one or two packets (400 mcg of nitroglycerin per packet) at the onset of an attack under the tongue.
One additional packet could be administered every five minutes as required. No more than three packets are recommended within a 15-minute period.