After a successful Pre-IND meeting with FDA, Respira Technologies, Inc. announces plans to submit an Investigative New Drug Application (IND) to FDA in 2022 as the world's first truly inhalable prescription smoking cessation therapy

- Respira successfully conducted a Pre-IND meeting with FDA for its breakthrough combination drug device application under the 505 (b)(2) drug approval pathway
Published: Nov. 30, 2021 at 6:00 AM CST

LOS ANGELES, Nov. 30, 2021 /PRNewswire/ -- Respira Technologies, Inc announced today, after a successful and collaborative Pre-IND meeting with FDA's Center for Drug Evaluation and Research (CDER), the company plans to submit an IND to FDA in 2022 to support its prescription combination drug device application to be the world's first inhalable nicotine replacement therapy (NRT).

Respira Technologies, Inc.
Respira Technologies, Inc.
Respira Technologies, Inc. announces plans to submit an Investigative New Drug Application (IND) to FDA in 2022

Smoking continues to be the world's leading cause of preventable death and disease.  According to the CDC and FDA, almost 60% of the approximately 40 million smokers in the U.S. want to quit, but can't due to the lack of efficacy of current cessation therapies. Most smokers trying to quit have used existing therapies and failed. As a result, quitting "cold turkey" remains the #1 method of cessation for smokers trying to quit smoking.

"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 high standards for both safety and efficacy," said Mario Danek, CEO and Founder of Respira Technologies.

Commenting on the recent Pre-IND meeting with FDA, Danek added, "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. 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."

Respira's combination device the RespiRxTM is the first truly patient-focused and ultra-portable handheld Vibrating Mesh Nebulizer (VMN) for local and systemic treatments. The RespiRxTM combines breakthrough performance of an inhalable aerosol, superior human factors engineering and satisfies FDA's rigorous safety standards for medical devices. The device is a handheld, portable with a pre-filled disposable drug-product containing cartridge that operates in any direction being held. Respira has patents granted and multiple in review for its device design and drug product formulations.

Respira will continue to share data and engage with FDA prior to the IND submission. In the planned 2022 IND submission to FDA, Respira will seek approval to begin human clinical studies demonstrating the efficacy of drug delivery and of its proposed cessation therapy with the goal of dramatically improving long-term quit rates and helping millions more smokers break the chains of addiction to nicotine.

About Respira Technologies, Inc.

Respira is based in Los Angeles, CA and was founded by CEO Mario Danek in 2018 to build cutting-edge drug delivery platforms that improve patient outcomes through superior device technologies.

Respira is backed by venture firms: Blue Ledge Capital, Evolution VC Partners, DG Ventures and Poseidon Asset Management.

www.respiratechnologies.com

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