NovaDel receives FDA approval of NitroMist

NitroMist 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.

“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,” commented Jan Egberts, CEO of NovaDel.

Data from the NitroMist clinical trials demonstrate the drug’s efficacy in the treatment of angina. In a study, doses of 0.2, 0.4, and 0.8mg of nitroglycerin delivered by NitroMist were compared to 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.

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