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.–(BUSINESS WIRE)–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
