- Phase 1 clinical trial for smoking cessation expected to dose first patient in 4Q 2024 - - The study will evaluate the pharmacokinetics, safety and tolerability of the RespiRx TM Nicotine Inhaler compared to Nicotrol ® Inhaler and combustible cigarettes - RICHMOND, Va. , Oct. 1, 2024 /PRNewswire/ -- Qnovia, Inc.
, a pharmaceutical company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRx TM , today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its lead asset, RespiRx TM Nicotine Inhaler (QN-01).
The RespiRx is a drug device combination product that is the first truly inhalable nicotine replacement therapy (NRT) to assist smokers attempting to quit smoking. Smoking continues to be the leading cause of preventable death and disease in the U.S.
Over half of the approximately 28 million smokers in the U.S. attempt to quit each year and less than one in ten is successful.
Current NRT treatment options, 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. The Company will initiate a Phase 1, randomized, crossover, open-label trial in the U.S.
to determine the pharmacokinetics, safety, and tolerability following self-administration of nicotine-containing products in up to 24 healt.
