FDA APPROVES NOVADEL'S NITROGLYCERIN SPRAY

NovaDel Pharma announced that NitroMist (nitroglycerin lingual aerosol) has been approved by the FDA for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. NitroMist is NovaDel's first approved product using its proprietary oral spray technology. The North American commercial rights for NitroMist have been licensed to Par Pharmaceutical.

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 resulting from an acute coronary syndrome and must be treated quickly, according to NovaDel.

Data from NitroMist clinical trials demonstrate the drug's efficacy in the treatment of angina. In a double-blind, single-center, placebo-controlled, four-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 with 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 with placebo.

NovaDel expects to receive a milestone payment from Par Pharmaceutical as a result of this approval.