Monday, January 30, 2017

Espero Pharmaceuticals Receives FDA Approval for GoNitro (nitroglycerin) Sublingual Powder

Espero Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, 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, GoNitro is the first and only short-acting nitrate in a stabilized crystal granule form available in single dose packets.
Skeletal formula of zwitterionic nitroglycerin
“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,” 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 GoNitro 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).
Each individual packet of GoNitro contains 400 mcg of nitroglycerin. The clinical data indicate that the sublingual absorption of nitroglycerin is higher following the administration of GoNitro compared to Nitrolingual® Pumpspray (nitroglycerin lingual spray) which was launched in 1997 and is currently marketed by Espero in the U.S. GoNitro was approved by the FDA via the 505(b) regulatory pathway.
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.
“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.
GoNitro will be available in the second half of 2016 and promoted by Espero’s specialty sales force at launch.

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