Qnovia wins FDA nod for nicotine inhaler as smoking cessation therapy

Qnovia announced that the FDA cleared its investigational new drug (IND) application for the RespiRx smoking cessation inhaler (QN-01).

RespiRx, a drug-device combination product, offers inhalable nicotine replacement therapy (NRT) to assist in the quitting of smoking. IND clearance allows Qnovia to initiate a Phase 1 trial in the U.S. to determine the pharmacokinetics, safety, and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes.

The company designed the QN-01 therapy to meet the need for safe and effective pharmacotherapies that address the shortcomings of currently available nicotine replacement therapies (NRTs). According to Qnovia, existing pharmacotherapies lack the rapid onset and peak levels of nicotine delivery. They fail to effectively alleviate cravings and withdrawal symptoms during a quit attempt.

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