FDA clears investigational new drug application for inhaled nicotine replacement therapy

Key takeaways:

• There is a current lack of new, approved smoking cessation therapies.
• The RespiRx Nicotine Inhaler may address this absence.
• Enrollment for the trial assessing this product is expected to be met this month.

The FDA has cleared an investigational new drug application for the RespiRx Nicotine Inhaler (QN-01), an inhaled nicotine replacement therapy, according to a press release.

With this authorization, the release says that the product’s manufacturer, Qnovia, now seeks to establish the pharmacokinetic, safety and tolerability profiles of the RespiRx Nicotine Inhaler in current adult smokers vs. the Nicotrol Inhaler (Pfizer) and cigarettes. This will be achieved via a randomized, crossover, open-label, phase 1 U.S. trial.

The trial’s enrollment goal of 24 adults is expected to be met this month, and the first patient is projected to be dosed in the fourth quarter of 2024, according to the release.

Healio spoke with Brian Quigley, BA, CEO of Qnovia, to learn more about current nicotine replacement therapies (NRTs), key features of the RespiRx Nicotine Inhaler and the phase 1 trial.

Healio: Why is there a need for another NRT product?

Quigley: There hasn’t been a new smoking cessation medicine approved in 20 years, and the existing NRTs are even older than that. Today, more than half of all smokers try to quit each year, and the most common way of attempting to quit remains cold turkey. Less than 1 in 10 smokers are successful in their quit attempt, and as a result, smoking-related disease causes almost 500,000 deaths each year.

New medicines that can be more effective dramatically change this. Existing NRTs deliver nicotine buccally or transdermally and do not deliver enough nicotine fast enough to alleviate craving and withdrawals. Considering this, there is a clear opportunity to improve the effectiveness of NRTs to improve outcomes for smokers who want to quit.

Healio: How is RespiRx suspected to be better than the current NRT options, and what sets it apart from these options?

Quigley: RespiRx is unique as it would be the first inhalable NRT that delivers the drug to the lung. The technology platform uses nebulization, which prevents the formation of thermal degradants and can deliver an aerosol that achieves a medical standard of safety. Inhaled delivery is critical to improving effectiveness of NRTs.

Qnovia’s first in-human study demonstrating the delivery in nicotine via inhalation resulted in significantly more rapid onset than NRT and achieved higher peak blood plasma concentrations, which is critical to alleviating withdrawals when the patient is feeling cravings.

Healio: Could you please explain the key features that make up RespiRx?

Quigley: The RespiRx is a handheld portable nebulizer platform. The device includes a handheld unit with a screen for patient feedback and dose tracking. The cartridge is a miniaturized maintenance-free nebulizer and holds the drug product. Nebulization is a proven medical technology for creating aerosols to deliver active pharmaceutical ingredients for a variety of treatments and does not use any heat to create an aerosol. The device also has user controls to prevent misuse and patient compliance.

Healio: What are the main endpoints for the planned randomized, crossover, open-label U.S. phase 1 trial? How long is the study period?

Quigley: The phase 1 study is a single-dose pharmacokinetic study that is expected to replicate the results from our first in-human study demonstrating pulmonary delivery with good tolerability among patients. This study is expected to confirm improvements in onset and peak blood plasma concentrations when compared with a reference NRT.

This will lead us to phase 2 where we will begin studies to evaluate efficacy, which is measured by abstinence from cigarettes.

Healio: There have been previous data on RespiRx. What did you discover in this study? How are these data shaping the phase 1 U.S. trial?

Quigley: The previous data were generated from a study conducted in the EU. The original study was designed to evaluate pharmacokinetic profiles of different target doses. In addition, across all study arms, we evaluated Tmax, or the time to reach maximum concentration, and Cmax, or the maximum observed concentration, in comparison to published data for a reference cigarette and reference NRT. The study helped identify the target dose for the U.S. phase study.

Reference:

• Qnovia, Inc. announces FDA clearance of IND application for lead asset RespiRx Nicotine Inhaler as a prescription smoking cessation therapy. https://www.prnewswire.com/news-releases/qnovia-inc-announces-fda-clearance-of-ind-application-for-lead-asset-respirx-nicotine-inhaler-as-a-prescription-smoking-cessation-therapy-302263046.html. Published Oct. 1, 2024. Accessed Nov. 4, 2024.