Qnovia Begins U.S. Phase 1 Trial for RespiRx™ Nicotine Inhaler

Qnovia, Inc., a pharmaceutical organization based in Richmond, Virginia, has taken a significant step forward in the development of smoking cessation therapies with the initiation of its Phase 1 clinical trial for the RespiRx™ Nicotine Inhaler. This innovative product stands out as the first truly inhalable nicotine replacement therapy (NRT) aimed at aiding smokers in their attempts to quit. The trial's primary focus is to evaluate the safety, tolerability, and pharmacokinetics of the RespiRx™ Nicotine Inhaler, which promises to offer a more effective alternative to traditional nicotine replacement methods such as gums and patches.

Smoking remains a leading cause of preventable disease and death in the United States. Despite the fact that over half of the 28 million smokers in the country attempt to quit annually, the success rate is alarmingly low, with less than 10% managing to stop smoking successfully. Current NRTs, which deliver nicotine through buccal or transdermal means, often fall short in effectiveness due to their slow and low-level nicotine delivery. In contrast, the RespiRx™ device offers a more direct and efficient means of nicotine delivery via inhalation.

The RespiRx™ Nicotine Inhaler is designed as a portable, handheld nebulizer. It administers medicine in the form of an inhaled mist through metered dose cartridges, providing a more immediate and potent nicotine delivery method. Brian Quigley, CEO of Qnovia, expressed his enthusiasm about the trial, highlighting the company's commitment to transforming the landscape of smoking cessation treatments. Quigley emphasized the importance of this development, noting the lack of novel treatment options in recent decades and the significant impact that a new, effective therapy could have for millions of smokers seeking to quit.

The Phase 1 trial is set to explore the potential of this novel inhaler to meet the urgent need for more effective smoking cessation solutions. Conducted in Overland Park, Kansas, by Dr. Vince Clinical Research, the trial is structured as a randomized, crossover, open-label study. It aims to assess the self-administration of the RespiRx™ Nicotine Inhaler, contrasting its effects with those of the Nicotrol® Inhaler and traditional combustible cigarettes. Up to 24 healthy adult smokers will participate, with key endpoints including measures of plasma nicotine levels and the time taken to reach peak concentration.

Qnovia has already achieved promising results with its proprietary drug/device combination, which showed dose-dependent pharmacokinetics and effective pulmonary delivery in an initial human study conducted in the UK. This success supports the advancement of the RespiRx™ Nicotine Inhaler as a viable smoking cessation tool.

Looking ahead, Qnovia has outlined upcoming milestones, including the anticipated release of clinical data from the Phase 1 study in the second quarter of 2025, and the submission of a Clinical Trial Application for the RespiRx™ Nicotine Inhaler in the UK in the latter half of 2025. Founded by Mario Danek in 2018, Qnovia is dedicated to developing advanced inhalation device technologies to improve patient outcomes across various medical conditions, including asthma, COPD, and pain management. The RespiRx™ platform exemplifies the company's innovative approach, offering a versatile nebulizer that operates effectively regardless of the patient's position, underscoring its potential to revolutionize drug delivery and treatment efficacy.