According to PR Newswire's report on January 7th, the US pharmaceutical company Qnovia, Inc. announced that the first patient in the US has been administered with RespiRx™ nicotine inhaler (QN-01) in the phase I clinical trial as a smoking cessation therapy.
RespiRx™ is a drug delivery device that combines a portable handheld nebulizer with a metered dose medication cartridge to administer medication in aerosol form.
Qnovia's CEO Brian Quigley stated,
We are pleased to have administered medication to the first patient in our first clinical trial, aimed at addressing global cigarette use issues and innovating smoking cessation treatment. Overall, we believe today's news represents Qnovia's official transformation into a biopharmaceutical company, developing the next generation of smoking cessation therapies.
This clinical trial aims to address the need for effective and easily accessible smoking cessation therapy, evaluating the pharmacokinetics, safety, and tolerability of RespiRx™. The trial is a randomized crossover open-label study, including up to 24 healthy adult smokers. The primary endpoints are the maximum concentration, AUC 0-30, and Tmax of plasma nicotine after baseline adjustment. The study is being conducted by Vince Clinical Research Company in Overland Park.
The company expects to release the first phase trial data of the RespiRx™ nicotine inhaler in the second quarter of 2025, and submit a clinical trial application in the UK in the second half of 2025.
Qnovia, Inc. is a US-based platform medical technology and pharmaceutical company founded by Mario Danek in 2018. It focuses on developing and commercializing proprietary inhalation device technology to improve patient outcomes. Its flagship product, RespiRx™, is a medication-grade inhalation drug delivery system based on a cartridge, designed to help smokers quit smoking.
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