Mitch Zeller, who previously led the Food and Drug Administration’s Center for Tobacco Products, has joined a company hoping to release what could be the first prescription inhaled smoking cessation therapy product.
Richmond, Virginia-based Qnovia Inc. has submitted an application for its QN-01 product to the FDA’s Center for Drug Evaluation and Research (CDER), the company said. The new technology (pictured), about the size of a vaping device, could be a “potential game-changer” for smokers looking to quit, said Zeller, who will advise Qnovia on its regulatory strategy.
“There have been no new therapies approved for smoking cessation in over a decade,” Zeller said. “Although most smokers are concerned about their health and want to quit, existing products simply don’t work all that well in the real world. Qnovia is taking a unique approach and is committed to developing a safe and effective medical therapy that can help more smokers successfully quit.”
Zeller was director of the FDA’s CTP from March 2013 to April 2022. He shaped regulatory policy and oversaw the agency’s premarket tobacco product application (PMTA) process for authorizing new tobacco products.
Cigarette smoking is estimated to cause more than 480,000 deaths annual, according to the Centers for Disease Control and Prevention. The FDA is taking steps to reduce smoking-related deaths and disease through initiatives like proposing a ban on menthol flavored cigarettes and all flavored cigars, and by proposing a lower nicotine level in cigarettes.
Zeller’s leadership and understanding of the public health, policy, product and regulatory environment around smoking cessation make him an important addition to Qnovia, the company said. In his advisory role, Zeller will help Qnovia with its policy and regulatory strategy that will advance a framework for the development of new smoking cessation therapies as the company moves through the drug approval process in the United States and other global markets.
“The successful development of QN-01 not only represents a potential breakthrough in smoking cessation treatment but also can validate Qnovia’s platform technology as we expand development in additional therapeutic areas including asthma, COPD, pain management, depression and anxiety,” Qnovia CEO Brian Quigley said.
Qnovia Inc., formerly Respira Technologies Inc., is a pharma company focused on developing and commercializing proprietary inhalation device technologies to improve patient outcomes. The company was founded by Mario Danek in 2018.
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