US pharmaceutical company Qnovia announces progress in clinical trial of nicotine inhaler, first patient completed medication

US pharmaceutical company Qnovia announces progress in clinical trial of nicotine inhaler, first patient completed medication

The first phase clinical trial of RespiRx™ Nicotine Inhaler for smoking cessation therapy by the US pharmaceutical company Qnovia has been initiated, and the first patient has been treated. The company expects to release the first phase trial data of RespiRx™ Nicotine Inhaler in the second quarter of 2025 and submit a UK clinical trial application in the second half of 2025.

According to PR Newswire on January 7, the US pharmaceutical company Qnovia, Inc. announced that its RespiRx™ Nicotine Inhaler (QN-01) as a smoking cessation therapy in the United States has been treated with the first patient.

RespiRx™ is a drug-device combination product designed as a portable handheld nebulizer that inhales the drug in atomized form through a metered dose cartridge.

Brian Quigley, CEO of Qnovia, said,

"We are pleased to dose the first patient in our Phase 1 clinical trial, which aims to address the global problem of cigarette use and revolutionize smoking cessation treatment options. Overall, we believe today's news represents Qnovia's official transformation into a biopharmaceutical company developing the next generation of smoking cessation therapies."

The clinical trial is primarily designed to address the need for effective and accessible smoking cessation therapies and evaluate the pharmacokinetics, safety and tolerability of RespiRx™. The trial is a randomized, crossover, open-label study involving up to 24 healthy adults who currently smoke, with the primary endpoints being the maximum baseline-adjusted plasma nicotine concentration, AUC 0-30 and Tmax. The study was conducted by Vince Clinical Research in Overland Park.

The company expects to release Phase 1 trial data for RespiRx™ nicotine inhaler in the second quarter of 2025 and submit a UK clinical trial application in the second half of 2025.

Qnovia, Inc. is a U.S. platform medical technology and pharmaceutical company founded by Mario Danek in 2018. It focuses on developing and commercializing proprietary inhalation device technologies to improve patient outcomes. Its first-of-its-kind RespiRx™ is a cartridge-based medical-grade inhaled drug delivery system that helps smokers finally quit smoking.