The FDA has approved NitroMist (Nitroglycerin Lingual Aerosol) for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. It is NovaDel’s (Flemington, NJ) first product approval utilizing the company’s proprietary oral spray technology.
The North American commercial rights for NitroMist have been licensed to Par Pharmaceutical Companies, Inc.
Data from the NitroMist clinical trials demonstrate the drug's efficacy in the treatment of angina.
Administration of NitroMist is contraindicated in patients who are using PDE5 inhibitors such as Viagra (sildenafil), Levitra (vardenafil), and Cialis (tadalafil). These products have been shown to potentiate the hypotensive effects of nitrate drugs such as NitroMist. NitroMist(TM) is also contraindicated in patients with severe anemia, increased intracranial pressure, or with a known hypersensitivity to nitrates or nitrites. Excessive use may lead to the development of tolerance. Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. The drug should therefore be used with caution in patients who may be volume-depleted or who are already hypotensive. Nitroglycerin produces dose-related headaches, which may be severe.
For full prescribing information visit www.novadel.com.