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Akrimax Pharmaceuticals, Introduces NitroMist(R) (Nitroglycerin Lingual Aerosol) 400mcg/Spray


3/16/2011 8:27:18 AM

CRANFORD, N.J., March 16, 2011 /PRNewswire/ -- Coronary artery disease (CAD), also known as coronary heart disease, is the most common type of heart disease, currently affecting about 17 million Americans(1). Most of these people suffer from a common symptom of CAD known as angina pectoris. For over 100 years, physicians have treated acute angina with nitrates, the most common form being nitroglycerin(2). Considered the gold standard in treating acute angina, nitroglycerin tablets have had problems with diminished stability and potency once dispensed(3-5). In recent years, nitroglycerin sprays were introduced and have alleviated much of the potency and stability concerns associated with the storage of tablets. Studies have shown that nitroglycerin sprays are capable of providing a more rapid form of symptom relief in most angina patients(6).

NitroMist® (Nitroglycerin Lingual Aerosol 400 mcg) is indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. It provides nitroglycerin in a rapidly absorbed, mentholated spray formulation, specifically designed for use on or under the tongue. NitroMist is available in a fully sealed aerosol delivery system, providing a shelf life of 36 months. NitroMist contains no ethyl alcohol.

Nitroglycerin sprays are proven to relieve the symptoms of angina significantly faster than tablets in most patients(6).

Wayne Anderson, Akrimax' President and CEO stated, "Akrimax is committed to providing health care providers and their patients with therapies that can make an important difference in the lives of patients. We believe NitroMist is an excellent example of this. NitroMist is the second new product that Akrimax has brought to market in the past year. Akrimax also has expanded its sales force by a third in order to educate health care providers about NitroMist and its other promoted brands, Tirosint and Inderal LA." Once primed, NitroMist's unique aerosol delivery system ensures consistent delivery with a propellant-driven, metered dose.*

Indications and Usage:NitroMist® is a nitrate vasodilator indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Important Safety Information: NitroMist® should not be used in patients who are using phosphodiesterase type 5 inhibitors, such as those used for the treatment of erectile dysfunction, which have been shown to potentiate the hypotensive effects of organic nitrates. NitroMist should not be used in patients with severe anemia, in patients with increased intracranial pressure, and in patients with a history of hypersensitivity to this or other nitrates or nitrites. Skin reactions consistent with hypersensitivity have been observed with organic nitrates. NitroMist should be used with caution if patients have low systolic blood pressure, are undergoing diuretic therapy, or are undergoing tissue-type plasminogen activator therapy.

Co-administration of aspirin and nitroglycerin has been reported to increase nitroglycerin levels and intravenous nitroglycerin reduces the anticoagulant effect of heparin, so activated partial thromboplastin times should be monitored. Oral administration of nitroglycerin increases bioavailability of ergotamine, so concomitant use of ergotamine and related drugs should be avoided.

Excessive use may lead to the development of tolerance.

Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris. The benefits of NitroMist in patients with acute myocardial infarction or congestive heart failure have not been established. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

Nitroglycerin produces dose-related headaches, which may be severe. Tolerance to headaches occurs. The most common adverse reactions are headache, flushing, hypotension and syncope.

[Web version]

Click here for full Prescribing Information

[Email version]

Please see attached full Prescribing Information

*Priming NitroMist: After receiving a new prescription or refill, patients should remove the plastic cap, place forefinger on actuator button, and press 10 times. NitroMist is now primed for 6 weeks and ready to use. If not used for more than 6 weeks, the NitroMist bottle can be adequately reprimed with 2 sprays.

NitroMist is a registered trademark of Novadel Pharma, Inc., used by permission.

For more information about NitroMist please visit www.nitromist.com

About Akrimax

Akrimax Pharmaceuticals, LLC is a privately held, fully integrated next-generation specialty pharmaceutical company that acquires, markets, and develops products to address disease states related to cardiovascular, metabolic and endocrine diseases. Based in Cranford, NJ, Akrimax pursues unsurpassed quality in the development, production, manufacturing, distribution, and commercialization of a full range of top-quality pharmaceutical products.

For more information on NitroMist or other Akrimax products, please contact

Jim Misner or Aleen Hosdaghian of Akrimax Pharmaceuticals, LLC, 908.372.0500.

To learn more about Akrimax, please visit www.akrimax.com

References: 1. Heart disease and stroke statistics2010 update. American Heart Association. 2010: pp1-36. 2. Coronary artery disease. http://adam.about.com/reports/Coronary-artery-disease.htm. Updated 5/15/2009. Accessed 2/22/2011. 3. O'Hanrahan M, McGarry K, Kelly JG, et al. Diminished activity of glyceryl trinitrate. Br Med J. 1982;284(6323):1183-1184. 4. Davis's Drug Guide.com. http://www.drugguide.com/ddo/ub/view/Davis-Drug-Guide/51548/all/nitroglycerin?q=nitroglycerin. Published 2010. Accessed June 21, 2010. 5. Tallett ER. Stability of glyceryl trinitrate tablets (letter). Br Med J. 1982;284:1403. 6. Vandenburg MJ, Wight, LJ, Griffiths GK, et al. Sublingual nitroglycerin or spray in the treatment of angina. Br J Clin Pract. 1986;40(12):524-527.

Aleen Hosdaghian

Akrimax Pharmaceuticals, LLC

908-372-1223

ahosdaghian@akrimax.com



SOURCE Akrimax Pharmaceuticals, LLC



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