Qnovia, Inc. CEO Speaks at FDA and NIH Public Meeting to Encourage Innovation of Smoking Cessation Treatment Options

Speech highlights the need for inhalation-based prescription nicotine replacement therapy to address efficacy shortfalls of current treatment options

RICHMOND, Va., Oct. 21, 2024 /PRNewswire/ -- Qnovia, Inc. announced its CEO is speaking publicly to FDA and NIH at the joint agency public meeting on Advancing Smoking Cessation today at FDA's White Oak Campus. Qnovia is a pharmaceutical company that recently announced the clearance of its Investigational New Drug (IND) application by FDA for the RespiRx™ Nicotine Inhaler (QN-01), a prescription inhaled smoking cessation medicine.

"I am encouraged by the opportunities recently outlined by FDA and NIH for pursuing innovation in smoking cessation, an area with no new therapies approved in several decades. A modernization of the approach to smoking cessation medicines is overdue, and I am hopeful today's discussion will lead to more innovation in the industry," stated Brian Quigley, Chief Executive Officer of Qnovia.

"The currently available nicotine replacement therapies (NRTs) deliver nicotine buccally or transdermally, resulting in suboptimal nicotine concentrations and ultimately a failure to provide relief from cravings or withdrawals in the real world. We believe an NRT that safely delivers pharmaceutical grade nicotine using the pulmonary route of administration can address the shortcomings of existing therapies. We are committed to directly addressing this unmet public health need through the development of our lead asset QN-01, a prescription inhaled smoking cessation therapy. We will be advancing QN-01 through Phase 1 clinical trials this year and are committed to continuing to engage with regulators as we advance through the regulatory process in both the U.S. and U.K."

Qnovia submitted a full copy of its remarks to FDA and NIH to the public docket for comments and will be available once posted by FDA at: www.regulations.gov/document/FDA-2024-N-4085-0001

To view the webcast, participants can register until 9am ET on October 21 via the link on the meeting notice posted on the federal register.

About Smoking Cessation

Smoking continues to be the leading cause of preventable death and disease in the world, leading to almost 8 million direct and indirect deaths annually. Over half of the 28 million smokers in America and 6 million smokers in the U.K. attempt to quit every year. However, very few of these quit attempts are successful, and existing pharmacotherapies are severely underutilized due to the lack of real-world efficacy. As a result, quitting "cold turkey" remains the most popular way to quit smoking, though this is also the least effective option. QN-01 is designed to meet the urgent need for a safe and effective pharmacotherapy with the potential to be a breakthrough in meeting the urgent need of millions of smokers who want to quit but can't.

About Qnovia, Inc.

Qnovia, Inc., formerly Respira Technologies, Inc., is a pharmaceutical company focused on developing and commercializing proprietary inhalation device technologies to improve patient outcomes across a growing range of indication areas. Qnovia sees significant opportunity to utilize its novel drug delivery technologies to improve the treatment of asthma, COPD, vaccine delivery, pain management, and infectious diseases using generic and select investigational new drugs. The company was founded by Mario Danek in 2018 to build cutting-edge drug delivery platforms that improve patient outcomes through superior device technologies. The company can be found at www.qnovia.com.

SOURCE Qnovia, Inc.