Qnovia Aiming For 2025 Approval Of Heatless Nicotine Nebulizer

Pharma startup Qnovia Inc. is hoping to replace nicotine vaping devices and smoking-cessation gums, patches and pills with a heatless nebulizer for the millions of people who would like to quit cigarettes.

Founded in 2018 as Respira Technologies and led by former Altria Group executive Brian Quigley, the company rebranded itself in September as Qnovia and raised $17 million from several venture capital entities.

Its first product in development is RespiRx, which is a pocket-sized device that uses mesh-vibration technology to create an inhalable aerosol, as opposed to ultrasonic nebulizers.

The result is fast delivery of nicotine to provide instant relief of the physical sensations that contribute to nicotine cravings.

According to Quigley, Qnovia’s CEO, while nicotine vaping via heated devices is considered less harmful than burning and inhaling tobacco, vaping still exposes users to harmful substances.

In the following interview—edited for brevity and clarity—Quigley explains Qnovia’s intended path to approval by the U.S. Food and Drug Administration to obtain prescription status for RespiRx.

CPG Insider: Nicotine vapes can’t be legally marketed as smoking cessation devices, right?

Quigley: Correct. E-cigarettes have their own pathway to get to market that’s regulated by the Center for Tobacco products at the FDA, and those products cannot make cessation claims. To make a cessation claim and to be approved by the FDA as a therapy to help a smoker quit, you have to go through the Center for Drug Evaluation and Research—which regulates pharmaceutical and over-the-counter products.

CPG Insider: What’s wrong with using vapes as an alternative to cigarettes?

Quigley: Technically speaking, the problem with the existing base of e-cigarettes is they use a heating mechanism to create an aerosol that the consumer then inhales. With that process of heating—although it exposes consumers to less carcinogens than a conventional cigarette—there is still the presence of potentially harmful constituents and carcinogens.

CPG Insider: How would RespiRx differ from, say, nicotine gum?

Quigley: After decades of use, nicotine gums are actually labeled for what we call ongoing use—for a smoker who’s trying not to smoke to be able to use them forever.

In our initial application, we are very specifically proposing a 12-week use regimen where RespiRx could be prescribed for 12 weeks for people trying to quit. If they fail, they would be able to get up to two prescriptions a year to help them to quit.

CPG Insider: What’s your hoped-for FDA approval timeline?

Quigley: We conducted our pre-Investigational New Drug meeting with the FDA last year. The next step is to submit an IND, in which you share all your safety data and inhalation toxicity studies with the FDA so they can approve you to begin clinical studies. Our goal is to be approved in 2025.

CPG Insider: Qnovia says it has other potential uses for RespiRx beyond nicotine delivery for things like asthma, pain management and vaccines. Is it possible it could also deliver THC?

Quigley: The short answer is, there is a massive opportunity to improve the safety of cannabinoids broadly. A study published in Canada recently highlights a very obvious problem: When you show people a picture of a cigarette and ask what comes to mind, they say things like death, lung disease and cancer. When you show people a picture of a joint and ask what comes to mind, they say plant medicine, wellness and relaxation.

What people are missing is, what causes the harm and exposure to carcinogens is combustion—the fact that you’re burning something and inhaling it.

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