HQ Team
October 7, 2024: The US Food and Drug Administration (FDA)has cleared Qnovia Inc’s nicotine inhaler RespiRx for clinical trial.
The US pharmaceutical company plans to initiate a Phase 1 clinical trial in the U.S. by the end of this 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 clinical trial in the country in 2025.
The trials will assess the pharmacokinetics, safety, and tolerability of the RespiRx compared to existing nicotine inhalers and combustible cigarettes.
Addressing a public health crisis
Smoking remains the leading cause of preventable death in the world. The World Health Organization (WHO) has identified the tobacco epidemic as one of the biggest global public health threats. It kills over 8 million people annually.
In the U.S., over 28 million smokers attempt to quit each year. Current nicotine replacement therapies (NRTs), such as gums and patches, have proven less effective due to their slow delivery methods. The RespiRx inhaler aims to provide a more effective solution by delivering nicotine through inhalation, which offers faster absorption and potentially better outcomes for those seeking to quit smoking.
The RespiRx is designed to be breath-activated, allowing users to control their nicotine intake precisely. Each cartridge delivers a specific dose of nicotine, and the device tracks real-time dosing to help users follow a structured step-down regimen over 12 weeks.
Expert insights on smoking cessation needs
Mitch Zeller, Qnovia’s regulatory advisor, emphasized the urgent need for innovative smoking cessation products, noting that no new treatment options have been approved in over two decades. He highlighted that many smokers still rely on “cold turkey” methods, which are often ineffective. The introduction of RespiRx is seen as a critical step towards providing smokers with better tools to combat tobacco dependence
Future
Qnovia plans a randomized Phase 1 trial comparing it against 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.
Possible side effects include chances of overdose if taken with other nicotine substances, allergic reactions, headaches, and respiratory issues. It is recommended to take it under medical supervision if already suffering from heart and respiratory problems.
