The phase 1 trial evaluates the nicotine inhaler as a smoking cessation therapy, aiming to improve nicotine delivery and support smokers in quitting.
RT’s Three Key Takeaways:
- Phase 1 Trial Underway: Qnovia has dosed the first patient in a US-based phase 1 trial of the RespiRx Nicotine Inhaler, designed to evaluate its pharmacokinetics, safety, and tolerability as a smoking cessation therapy.
- Innovative Inhaled Approach: RespiRx aims to offers a faster and more effective nicotine delivery method compared to traditional nicotine replacement therapies like patches and gum.
- Comparative Study Design: The trial includes a randomized, crossover evaluation comparing the RespiRx Nicotine Inhaler with the Nicotrol Inhaler and combustible cigarettes in up to 24 smokers, aiming to assess its potential as a superior alternative for quitting smoking.
Qnovia Inc, a pharmaceutical company developing inhaled therapeutics across a variety of indication areas leveraging its inhaled drug delivery platform, the RespiRx, announced the first patient was dosed in its phase 1 clinical trial evaluating RespiRx Nicotine Inhaler (QN-01) as a smoking cessation therapy in the US.
Smoking continues to be the leading cause of preventable disease and mortality in the US. Over half of the approximately 28 million smokers in the country attempt to quit each year and less than one in 10 is successful. Current nicotine replacement therapies (NRT), including nicotine gums and patches, are less effective as they all deliver nicotine slowly and at low levels due to buccal or transdermal delivery when compared to delivery via inhalation, according to a release from Qnovia.
[RELATED: Next-Gen Voke Nicotine Inhaler for Smoking Cessation Approved in UK]
The RespiRx is a drug-device combination product that offers an inhalable NRT to assist smokers attempting to quit smoking. It is a portable, hand-held nebulizer that delivers medicine as an inhaled mist through metered dose cartridges.
“We are delighted to have dosed our first patient in our phase 1 study as we strive to address the global epidemic of combustible tobacco use and transform the treatment landscape for smoking cessation,” says Brian Quigley, chief executive officer of Qnovia, in a release. “Smoking remains one of the most challenging addictions to overcome, and it has been several decades since we have seen novel treatment options available to patients. The commencement of our phase 1 study in the US underscores our commitment to bringing an innovative therapy to the market to redefine what is possible for the millions of smokers who are looking to quit.”
Study Methodology and Design
The phase 1 study aims to address the need for effective and accessible smoking cessation therapies and is designed to assess the pharmacokinetics, safety, and tolerability of RespiRx Nicotine Inhaler in individuals looking to quit smoking. The study is a randomized, crossover, open-label trial evaluating the self-administration of RespiRx Nicotine Inhaler, Nicotrol Inhaler, or combustible cigarettes in up to 24 healthy adult subjects who currently smoke combustible cigarettes.
The study is being conducted by Dr. Vince Clinical Research, a clinical research organization based in Overland Park, KS.
Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing RespiRx Nicotine Inhaler in the UK. It has received FDA clearance of its Investigational New Drug application.
Photo caption: RespiRx Nicotine Inhaler
Photo credit: Qnovia Inc
