Espero Pharmaceuticals Announces the Availability of FDA-Approved GONITRO™ (Nitroglycerin) Sublingual Powder in the U.S.
New Short-Acting Nitrate Powder Now Available in Single Dose Packets for Acute Relief of an Angina Pectoris Attack
JACKSONVILLE, Fla. (Sept. 27, 2016) – Espero Pharmaceuticals Inc., a privately held specialty pharmaceutical company, today announced the commercial availability of GONITRO™ (nitroglycerin) sublingual powder for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
GONITRO™ is a FDA-approved short-acting nitrate in a patented, stabilized crystal granule form available in single dose packets. Each individual packet of GONITRO™ contains 400 mcg of nitroglycerin, comparable to the most commonly dispensed strengths of both the nitroglycerin sublingual spray and sublingual tablet dosage forms. Clinical data indicates that the sublingual absorption of nitroglycerin is higher following the administration of GONITROTM compared to Nitrolingual® Pumpspray (nitroglycerin lingual spray) which was launched in 1997 and is also currently marketed by Espero in the U.S. GONITRO™ is the first new dosage form approved in its therapeutic category in nearly two decades.
“We are excited to provide GONITRO™ for acute relief of an angina attack to the more than 8 million patients in the U.S. suffering with stable angina due to coronary artery disease,” commented Quang Pham, Founder and CEO of Espero Pharmaceuticals. “Angina patients now have a convenient easy to use dosage form and the assurance of product potency when needed.”
Short-acting nitrates are the current standard of care for acute relief and prevention of angina pectoris attacks and are a Class I Recommendation according to the 2012 Guidelines for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease (SIHD) published by the American College of Cardiology Foundation / American Heart Association Task Force. “The practice guidelines state that every patient suffering from SIHD should be prescribed a short-acting nitrate for angina,” said Jeff Cole, President and CFO of Espero. “Current prescribing data indicate short-acting nitrates are significantly underutilized by the 15.5 million SIHD patients in the U.S., presenting an opportunity for GONITRO™ to play an important role in symptom management of this disease.”
“A key focus of our market introduction of GONITRO™ is the large, non-retail segment of the short-acting nitrate market,” added Sean Purdy, Vice President of Commercial Operations. “GONITRO™ will be in the hands of emergency medical service providers and front-line responders, who are frequently called to treat patients suffering angina attacks.”
Espero Pharmaceuticals is responsible for all U.S. commercial activities for GONITRO™ including promotion and distribution, under an exclusive licensing agreement with G. Pohl-Boskamp GmbH & Co. KG, (Pohl Boskamp), an established global leader in the short-acting nitrate market. Additional information about GONITRO™ can be found at www.esperopharma.com.
INDICATIONS AND USAGE
GONITRO is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
IMPORTANT SAFETY INFORMATION
GONITRO is contraindicated in patients with severe anemia, in patients who are taking PDE-5-Inhibitors and soluble guanylate cyclase (sGC) stimulators, in patients with acute circulatory failure or shock, in with severe anemia, and in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient. GONITRO may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure.
Warnings and Precautions
Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. Nitrate therapy may aggravate the angina caused by hypertrophic obstructive cardiomyopathy. Nitroglycerin produces dose-related headaches, especially at the start of nitroglycerin therapy, which may be severe and persistent but usually subside with continued use.
About Angina Pectoris
According to the American Heart Association, angina pectoris is the medical term for chest pain or discomfort due to coronary heart disease. It occurs when the heart muscle doesn’t get as much blood as it needs. This usually happens because one or more of the heart’s arteries is narrowed or blocked. This type of chest discomfort is relieved with rest, nitroglycerin or both. Nitroglycerin relaxes the coronary arteries and other blood vessels, reducing the amount of blood that returns to the heart and easing the heart’s workload. By relaxing the coronary arteries, it increases the heart’s blood supply. Heart disease is the leading cause of death in the U.S.
About Espero Pharmaceuticals
Espero Pharmaceuticals, Inc., www.esperopharma.com, headquartered in Jacksonville, Florida, is an emerging growth specialty pharmaceutical company engaged in maximizing the commercial value of proven treatments that improve the quality of life for patients. Espero is focused on compounds with proven safety and efficacy administered via novel delivery solutions in the cardiovascular and other specialty therapeutic categories. Through Jacksonville Pharmaceuticals, its wholly owned subsidiary, the company markets and distributes selected generic pharmaceutical products including the authorized generic version of Nitrolingual® Pumpspray (nitroglycerin lingual spray).