FDA Grants IND for RespiRx Inhalable Nicotine Replacement Therapy

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The FDA has cleared an investigational new drug (IND) application for RespiRx Nicotine Inhaler (QN-01; Qnovia, Inc), an inhalable nicotine replacement therapy (NRT). With the IND application approved, the device will be evaluated in a randomized, crossover, open-label phase 1 clinical trial to determine the NRT’s pharmacokinetics, safety, and tolerability.¹

QN-01 is a combination drug product that is designed to be the first inhalable prescription NRT for individuals who are trying to quit smoking. QN-01 is easy to use and uses a zero-maintenance cartridge-based medical grade inhaled drug delivery system. Each cartridge is filled aseptically and contains the drug product as well as a proprietary aerosol generating technology. It is breath activated by the user and delivers precise doses via inhalation while addressing cue induced relapse behavior. QN-01 tracks and displays real-time dosing to help patients successfully follow a 12-week step-down regimen to quit smoking. Additionally, all data are accessible on a device, smartphone, or both.^1,2

"There have been no treatment options for smoking cessation approved in the US in over 20 years. As a result, attempting to quit 'cold turkey' remains the most popular method of quitting smoking," said Mitch Zeller, policy and regulatory strategy advisor at Qnovia, in a news release. “There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit.”¹

The clearance comes after positive results from the first in-human study that assessed QN-01. The open-label phase 1 trial evaluated the delivery of QN-01 for 3 different nicotine dosing regimens to determine both the pharmacokinetics and safety profile of the drug delivery platform in 12 healthy adults who were smoking combustible cigarettes at the time of the study.³

The study confirmed dose-dependent pharmacokinetics of QN-01 delivered with the RespiRx NRT device. The mean maximum plasma concentration (Cmax) was higher (12.9 ng/ml), and the time to achieve maximum plasma concentration (Tmax ) was lower for QN-01 across all 3 studied dosing regimens (low: 7.9; mid: 9.4; and high: 14.6), demonstrating more favorable pharmacokinetics compared with existing inhaled NRT (Cmax: 2.3 ng/ml; Tmax: 15). Additionally, the drug-device combination was well-tolerated in all patients, with no observed serious adverse events (AEs) and only a few AEs, which were considered minor and typical of inhaled nicotine.³

“The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company. Our US clinical development plan is de-risked by the positive first-in-human data we generated last year in support of advancing QN-01 in the UK where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine replacement therapies," said Brian Quigley, CEO of Qnovia, in the news release. “We remain on track to dose our first patient in the fourth quarter of 2024, and in parallel, will be advancing to a pivotal clinical trial in the UK to support a [marketing authorization application] submission to the [Medicines and Healthcare Products Regulatory Agency] in 2026.”¹

Currently, NRT treatment options include nicotine gums and patches. These methods, which are buccal or transdermal delivery methods, are less effective because they deliver nicotine slower and at lower levels compared with delivery via inhalation.¹

“We believe our proprietary drug delivery platform has the potential to be a highly differentiated treatment option, not only for treatment of nicotine dependence, but for a wide variety of treatments that would benefit from inhaled drug deliver,” said Mario Danek, founder and chief technology officer of Qnovia, in the news release.¹

REFERENCES

1. PR Newswire. Qnovia, Inc. announces FDA clearance of IND application for lead asset RespiRx™ Nicotine Inhaler as a prescription smoking cessation therapy. News release. October 1, 2024. Accessed October 2, 2024. 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

2. Qnovia. Prescription NRT. Accessed October 2, 2024. https://www.qnovia.com/nrt/

3. Businesswire. Qnovia, Inc. announces positive results from first-in-human pharmacokinetic and safety study of lead asset QN-01, a prescription inhaled smoking cessation therapy. November 29, 2023. News release. Accessed October 2, 2024. https://www.businesswire.com/news/home/20231129757219/en/Qnovia-Inc.-announces-positive-results-from-first-in-human-pharmacokinetic-and-safety-study-of-lead-asset-QN-01-a-prescription-inhaled-smoking-cessation-therapy