NovaDel's NitroMist approved by FDA

New Jersey, USA-based NovaDel Pharma says that its drug NitroMist (nitroglycerin lingual aerosol) has received Food and Drug Administration approval as a treatment for angina pectoris associated with coronary artery disease. The company added that clearance for the product, which utilizes its proprietary oral spray technology, is a key step in validating its development platform.

Approval is based on the results of a double-blind, placebo-controlled study that enrolled 30 patients with stable angina pectoris. In the trial, single administrations of the agent at doses of 0.2mg, 0.4mg or 0.8mg were compared with placebo in terms of its impact on exercise tolerance. The results indicated that treatment brought about statistically-significant improvement in exercise capacity at all three doses, when compared with placebo. In addition, all three drug treated groups demonstrated a significant improvement in time to the occurrence of angina episodes versus placebo.

The firm added that, following the agency's approval, it anticipates receiving a milestone payment from fellow USA-based company Par Pharmaceuticals, which licensed North American commercial rights to the compound in September 2004 (Marketletters passim).