NovaDel Pharma (NVD) Receives FDA Approval Of NitroMist(TM)

FLEMINGTON, N.J.--(BUSINESS WIRE)--NovaDel Pharma Inc. (AMEX: NVD - News) today announced that NitroMist(TM) (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(TM) is NovaDel'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. (NYSE: PRX - News).

"The FDA's approval of NitroMist(TM) 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."

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. Nitroglycerin is most often, until now, placed as a dissolving pill under the tongue. It's mechanism of action is by relaxing the smooth muscle surrounding the arteries in the heart as well as reducing the volume of blood in the heart. Its effects are very short, 20 minutes, and is not indicated for maintenance therapy. This is a novel mechanism of delivery. I am keeping an open eye on this stock

The biotech/pharmaceutical company NVD is trading up 7% to $1.34.