Drug Application for Inhalable Nicotine Replacement Therapy

    Photo: Respira

    Respira Technologies plans to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration in 2022 for the world’s first inhalable nicotine-replacement therapy.

    “There is a void of innovation in solving the smoking crisis from traditional healthcare companies, and as a result, Big Tobacco is trying to position itself as the solution to the problem they’ve created. At Respira, we believe only our technology can effectively help end the death and disease caused by smoking while simultaneously meeting CDER’s [Center for Drug Evaluation and Research] high standards for both safety and efficacy,” said Mario Danek, CEO and founder of Respira Technologies, in a statement.

     “We are very pleased with the productive and collaborative discussion with FDA and have confidence that FDA’s guidance will help us achieve our goal to end the death and disease caused by smoking,” said Danek. “The Pre-IND is just the first of many major milestones Respira will achieve, and we are excited to advance our plans to submit our IND to begin human clinical studies.”

    In 2020, the company said it aims to disrupt a $618 billion market dominated by decades-old gums and patches from pharmaceutical companies as well as tobacco companies’ electronic nicotine-delivery devices with a nebulizer that converts nicotine to an aerosol.

    Respira’s senior management includes Chief Operating Officer Brian Quigley, who spent 16 years at Altria Group where he was CEO of the smokeless tobacco business from 2012 to 2018.