FDA Approves First ‘New Dosage Form’ for Stable Angina
US FDA approved Gonitro™ (nitroglycerin) sublingual powder of US based Espero Pharmaceuticals for acute relief of an angina pectoris attack due to coronary artery disease (CAD).
Gonitro™ became the first and the only stabilized crystal granular, short-acting nitrate which are available in single dose packets.
Angina pectoris also referred as stable angina can be described as a pain or discomfort in the chest caused due to CAD which is the most common type of heart disease. It occurs when the heart muscle does not get sufficient blood due to narrowed or blocked arteries of the heart. Nitroglycerin increases the blood supply to the heart by relaxing the coronary arteries and other blood vessels.
Figure 1. Pathophysiology of angina pectoris (Photo credit: El Camino Hospital, California, USA).
Gonitro™ is a sublingual nitrate which is a class of drug therapy. Sublingual nitrate is given to quickly prevent the chest pain (angina) in people with certain heart ailments like CAD. They are generally available as sublingual tablets which should be kept under the tongue inside the mouth for extended release to prevent angina attack. According to 2012 Stable Ischemic Heart Disease (SIHD) Guidelines, sublingual nitrate belongs to the category of Class I recommendation that means sublingual nitrate should be prescribed to all the patients with known SIHD.
Single packet of Gonitro™ contains 400 mcg of nitroglycerin. According to the clinical results of Gonitro, sublingual absorption of nitroglycerin is higher by Gonitro™ compared to the Nitrolingual® Pumpspray (nitroglycerin lingual spray) which was launched in 1997 and is marketed in the U.S. by Espero.
In US, more than 8 million peoples suffer from angina pectoris due to CAD. More than 10 million cases of CAD related stable angina can be seen every year in India.
Espero entered in an ‘exclusive licensing agreement’ with G. Pohl-Boskamp GmbH & Co. KG, (Pohl Boskamp) which is a global leader of short-acting nitrate market for the promotion and distribution of Gonitro™ nitroglycerin sublingual powder in the US market. Pohl Boskamp holds the patent for the stabilized granules containing glyceryl trinitrate (nitroglycerin).
Gonitro™ is expected to be available in the second half of 2016. At the launch of Gonitro™, it will be promoted by Espero by its speciality sales force.
“GONITRO™ is the first new dosage form in the short-acting nitrate category in nearly 20 years and we intend to educate healthcare providers and patients about our exciting new product immediately,” remarked Jeff Cole, President & CFO of Espero Pharmaceuticals.
Featured image credit: Human heart and pills. © guniita (Stock Photo ID: 52833853)