RespiRx is a drug-device combination product that delivers nicotine replacement therapy through an inhaler. Image credit: Josep Suria / Shutterstock.

Qnovia has received clearance from the US Food and Drug Administration (FDA) to start a clinical trial for its RespiRX nicotine inhaler as a replacement therapy for smoking.

The US-based company plans to start an open-label Phase I trial evaluating RespiRX in smokers, with the first patient expected to be dosed by the end of the year. Qnovia also intends to submit a marketing authorisation application (MAA) with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) by 2026, with plans to start a pivotal clinical trial in the country in 2025 to support the MAA.

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RespiRx is a drug-device combination product that delivers nicotine replacement therapy through an inhaler. Qnovia expects RespiRX device to be an alternative to current nicotine replacement therapies such as nicotine gums and patches, which are less effective than inhalers as they deliver nicotine slowly and at low levels.

The World Health Organization (WHO) has identified tobacco epidemic as one of the biggest global public health threats. Noting that it kills over 8 million people annually.

The crossover Phase I trial will evaluate the pharmacokinetics, safety, and tolerability of RespiRx in 24 healthy adults who smoke cigarettes. The study will compare RespiRx with combustible cigarettes and Pfizer’s nicotine inhalation system, Nicotrol. Pfizer discontinued the Nicotrol inhaler last year citing the unavailability of an essential resin needed to manufacture the inhaler.

“Our US clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine replacement therapies,” said Brian Quigley, Qnovia’s CEO.

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“The next step for our US program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol inhaler and combustible cigarettes in a head-to-head comparison.

The Phase I UK trial evaluated the pharmacokinetics of RespiRX in 12 healthy adults who smoke. The participants received three different doses of treatment delivered on subsequent days after a washout period. The study showed a higher mean maximum plasma concentration (Cmax), and a lower time to achieve the maximum plasma concentration (Tmax) across all three dose regimens, compared to reference nicotine replacement therapy. As a result, demonstrating superior pharmacokinetics compared to an existing inhaled nicotine replacement therapy.