Former FDA Tobacco Chief: Smokers Need a New Tool to Quit

According to foreign reports today, American pharmaceutical company Qnovia hopes the FDA will approve its RespiRx nicotine replacement device as a drug.<\/p>

Mitch Zeller, who retired from the FDA's Center for Tobacco Products about a year ago, joined Qnovia's advisory board last month. Qnovia is a young pharmaceutical company focused on developing inhalation therapies. What is the primary task of this respected former regulator? To consult the company on obtaining FDA approval for the first inhaled smoking cessation device as a drug.<\/p>

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“Here’s the reality: we’ve stagnated,” Zeller said. “We’ve done a great job preventing kids from becoming new smokers, but when it comes to existing adult smokers, they’re almost all addicted, and we need something new. We need some innovation.”
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Unlike nicotine gum or patches, Qnovia's product, named RespiRx, allows users to inhale nicotine, but it is not an e-cigarette, explained Qnovia CEO and former Altria smokeless tobacco division head Brian Quigley.
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According to the Centers for Disease Control and Prevention, about 40 million smokers will attempt to quit this year, but all will fail. Quigley attributes this to a lack of effective smoking cessation tools.<\/p>

While Zeller and Quigley did not describe their product as a game-changer, if successful, it likely will be.<\/p>

RespiRx gradually weans users off nicotine by providing a preset amount of nicotine doses throughout the day.<\/p>

E-cigarettes are appealing to smokers looking to quit because they provide the same effects of the addictive stimulant nicotine without the harmful tobacco smoke. Smokers often prefer e-cigarettes over nicotine replacement patches or gum because they deliver nicotine immediately, similar to cigarettes.<\/p>

However, most smokers who switch to e-cigarettes never truly overcome their nicotine addiction—they simply use a new, albeit less harmful, product.<\/p>

E-cigarettes are also regulated as tobacco products and must prove to the FDA that they are safe for adults and unlikely to attract children.<\/p>

Qnovia will seek approval as a medical product regulated by the agency's Center for Drug Evaluation and Research. The company must demonstrate through rigorous clinical testing that RespiRx is safe and effective.<\/p>

Qnovia expects to submit an Investigational New Drug application for RespiRx this year, which will allow the company to begin clinical trials. Qnovia aims to complete trials by 2025, at which point it will apply for approval. The FDA approval process could take another 10 months unless the agency reviews RespiRx through an expedited pathway.<\/p>

If approved, this will be Qnovia's first product on the market.<\/strong><\/p>