Qnovia announced that a Phase 1 trial of RespiRx inhaled nicotine, which is delivered via a handheld nebulizer, demonstrated that the nebulized formulation produced a Tmax comparable to cigarettes with lower plasma exposure. Qnovia had announced initiation of the study in January 2025. Results from a previous Phase 1 trial of were announced in November 2023.
According to the company, the trial enrolled 25 healthy adults and compared RespiRx to cigarettes and to Nicotrol Inhaler, which was discontinued in 2023. Cmax following 10 puffs of RespirRx was determined to be 8.7 ng/mL, with a Tmax of 7 minutes. Qnovia said that “urge-to-smoke” scores demonstrated a “meaningful reduction,” and the only side effect reported was a moderate cough.
Qnovia CEO Mario Danek commented, “We are very encouraged by the results of the first-in-human FDA trial of RespiRx. The findings show that our novel nicotine delivery method, via a cool mist, without any heating or combustion, matches the speed and habit loop of smoking and vaping without the carcinogens. As the first major NRT innovation in two decades, and first-ever truly inhaled investigational new drug-cleared NRT, RespiRx is uniquely positioned to globally drive towards a smoke-free generation and meaningfully reduce the burden of smoking-related disease.”
Read the Qnovia press release
