NovaDel Pharma Inc announced the results of a clinical study of its nitroglycerin lingual spray. In a randomized, double blind study of 30 patients whose average age was 66.5, three doses of the nitroglycerin spray (0.2, 0.4 and 0.8 mgs), was well tolerated and produced positive changes in hemodynamic endpoints at rest, and in the time until the development of exercise-induced angina.

The study showed highly statistically significant and clinically meaningful dose-dependant increases vs. placebo in the amount of treadmill exercise time needed to provoke the first onset of angina and to develop moderate angina.

The lingual nitroglycerin also extended the time to 1mm ST segment depression, consistent with the anti-ischemic mechanism underlying its beneficial effect on angina.

The ability of subjects to exercise to a higher rate-pressure product provides substantial evidence of the effectiveness of the lingually delivered nitroglycerin, the company said.

At rest, lingual spray nitroglycerin produced statistically significant increases in heart rate and decreases in systolic blood pressure compared to placebo.

Nitroglycerin is the drug of choice for the acute relief of attacks of angina pectoris because of its rapid onset of action. The currently marketed sublingual and buccal tablets achieve maximal blood levels in 6-8 minutes, but a spray formulation may be preferable because it eliminates the time required for tablet dissolution.

NovaDel's spray is expelled forcibly via a propellant, unlike a pump spray (which requires air to be introduced into the container on each actuation), thus eliminating the potential for hydrolysis of the active product. This is likely to offer a more reliably stable and more potent product over time.

The company recently filed US patents covering lingual spray versions of Imitrex (sumatriptan) and Zofran (ondansetron), both marketed in the US by GlaxoSmithKline, Ambien (zolpidem), marketed in the US by Sanofi and Xanax (alprazolam), sold by Pfizer and several generic producers.