NovaDel Pharma Inc has submitted a New Drug Application (NDA) for marketing approval of an aerosol nitroglycerin lingual spray for acute relief of an attack or acute prophylaxis of angina pectoris, a company release said.
The submission was made as a 505(b)(2) application, a form of NDA that references and relies both on data developed by NovaDel as well as on the wealth of historical data published in the literature. The 505(b)(2) was filed under PDUFA guidelines, under which a 10-month review is typical, the company said.
"This is an important step as it demonstrates NovaDel's capability to complete the pharmaceutical and clinical development activities to support a submission needed for marketing approval," said Gary A Shangold, NovaDel's president and CEO. This is the first of NovaDel's six Tier One priority products to reach the stage of NDA submission.
The next leading product in NovaDel's Tier One portfolio is a lingual spray version of GlaxoSmithKline's ImitrexÒ (sumatriptan), the leading migraine remedy. A pilot clinical pharmacokinetic study was initiated last month.
At the Annual Meeting of the American Association of Pharmaceutical Scientists held October 2003 in Salt Lake City, the company reported results of a randomized, double-blind, placebo controlled, four-way crossover study of its nitroglycerin lingual spray in 30 patients with chronic stable angina pectoris. The three nitroglycerin lingual spray doses (0.2, 0.4 and 0.8 mgs) were well tolerated and produced positive changes in hemodynamic endpoints both at rest and during treadmill exercise.
The study showed highly statistically significant and clinically meaningful dose-dependent increases vs. placebo in the amount of treadmill exercise time needed to provoke the first onset of angina and to develop moderate angina.
The important anti-ischemic effects of NovaDel's nitroglycerin lingual spray were also evidenced by the prolongation of the time to 1mm ST segment depression and the subjects' ability to exercise to a higher rate-pressure product.
The company earlier reported its plans to complete pilot clinical pharmacokinetic studies this year on lingual spray versions of three other currently marketed drugs: Glaxo's Zofran (ondansetron), Sanofi's Ambien (zolpidem), and Xanax (alprazolam), sold by Pfizer and several generic producers.