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Espero Pharmaceuticals Receives FDA Approval for GONITRO™ (Nitroglycerin) Sublingual Powder

Tuesday, June 14, 2016   (0 Comments)
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Espero Pharmaceuticals Receives FDA Approval for GONITRO™ (Nitroglycerin) Sublingual Powder

Available in Single Dose Packets, GONITROTM is Approved For Acute Relief of an Angina Pectoris Attack Due to Coronary Artery Disease

JACKSONVILLE, Fla.--()--Espero Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved GONITRO™ (nitroglycerin) sublingual powder for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. With this approval, GONITROTM is the first and only short-acting nitrate in a stabilized crystal granule form available in single dose packets.

"The FDA 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,” commented Quang Pham, Founder and CEO of Espero Pharmaceuticals. “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.”

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

GONITROTM was approved by the FDA via the 505(b) regulatory pathway. Each individual packet of GONITROTM contains 400 mcg of nitroglycerin. The clinical data indicate 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 currently marketed by Espero in the U.S.

Espero will promote and distribute GONITRO™ nitroglycerin sublingual powder in the U.S. market under an exclusive licensing agreement with G. Pohl-Boskamp GmbH & Co. KG, (Pohl Boskamp), an established global leader in the short-acting nitrate market. The United States Patent and Trademark Office awarded Pohl Boskamp Patent No. 9,101,592 B2 for stabilized granules containing glyceryl trinitrate (GTN or nitroglycerin) in August 2015.

“GONITROTM 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.

Espero expects GONITROTM to be available in the second half of 2016 and will promote by its specialty sales force at launch.

About GONITRO

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

Contraindications

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 strategic generic pharmaceutical products.

About G. Pohl-Boskamp GmbH & Co KG

Pohl-Boskamp is a privately owned business active in the international pharmaceutical market for 175 years with commercialized products in more than 45 countries. Through close collaboration with its partners abroad, Pohl-Boskamp focuses on developing and marketing products that positively impact patients’ quality of life. It operates in numerous healthcare sectors including pneumology, urology, parasitology, cardiovascular diseases, gastroenterology, sleep disorders and dermatology. For more information, visit http://www.pohl-boskamp.com/en/.

Contacts

For Espero Pharmaceuticals, Inc.
Ginny Walthour, 904-645-6200
gwalthour@burdetteketchum.com


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