NovaDel Pharma Receives FDA Approval of NitroMist
FLEMINGTON, N.J., November 3, 2006 -- NovaDel Pharma Inc. today announced that NitroMist (Nitroglycerin Lingual Aerosol) has been approved by the U.S. Food and Drug Administration (FDA) for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. NitroMist is NovaDelâ€™s first product approval utilizing its proprietary oral spray technology. The North American commercial rights for NitroMist have been licensed to Par Pharmaceutical Companies, Inc.
"The FDAâ€™s approval of NitroMist is a major milestone for NovaDel, as it represents the first approval of a drug using our proprietary oral spray technology. This achievement also further validates our ability to develop innovative drugs and gain FDA approval using the 505(b)(2) regulatory pathway," commented Jan Egberts, M.D., President and CEO of NovaDel. "With this approval, we will now focus our resources on the rapid advancement of our pipeline of compounds that promise to provide faster onset of action and more patient-friendly dosing. We are particularly excited about the potential of Sumatriptan Oral Spray and Zolpidem Oral Spray, which respectively target patients suffering from migraines and insomnia."
"We are very pleased that our partnership with NovaDel has successfully delivered an additional treatment option for those patients who suffer from acute angina," stated Paul Campanelli, Senior Vice President, Business Development & Licensing at Par. "At this time, we are finalizing our commercialization strategy for the product."
Data from the NitroMist clinical trials demonstrate the drugâ€™s efficacy in the treatment of angina. In a double-blind, single-center, placebo-controlled, 4-period crossover study in 30 subjects with stable angina pectoris, doses of 0.2, 0.4, and 0.8 mg of nitroglycerin delivered by NitroMist were compared to placebo. The primary efficacy endpoint was exercise tolerance as measured by time to development of moderate angina while on an exercise treadmill. The primary endpoint was achieved with all three nitroglycerin oral spray groups demonstrating statistically significantly increase in time to angina compared to placebo (p less than or equal to 0.0003).
NovaDel expects to receive a milestone payment from Par Pharmaceutical as a result of this approval.
NitroMist is an oral spray formulation of the drug most often used to treat angina pectoris, nitroglycerin. Angina is pain in the chest due to lack of blood and oxygen supply to the heart muscle resulting from an acute coronary syndrome and must be treated emergently. The American Heart Association estimates that over six million people in the United States suffer from angina.
Important Safety Information
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 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.
Source: NovaDel Pharma Inc.
Posted: November 2006
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