• by Les Luchter , Staff Writer, February 22, 2024

“Where’s an area in medicine where tens of millions of people are afflicted and looking for help, but we’re not innovating to create new therapies?” asks Brian Quigley, CEO of pharma startup Qnovia.

The answer, he tells Pharma & Marketing Insider, is smoking cessation, where “the medicines we’re giving them are 30 years old and really ineffective.”

Qnovia aims to end that decades-long drought with a non-combustible prescription Nicotine Replacement Therapy (NRT) delivered deep into the lungs through a nebulizer inhalation device similar to those asthma patients might use for Albuterol delivery. That process, Quigley says, replicates how smokers ingest cigarette smoke.

Like other NRT therapies, Qnovia works by delivering small amounts of nicotine into the bloodstream in order to alleviate cigarette cravings and withdrawal symptoms.

Qnovia’s process, Quigley says, works better because it gets the drug into the bloodstream quicker and at higher levels than other NRT methods.

To make this happen, Qnovia will be seeking FDA approval for the NRT device and drug in combination, a process it later hopes to repeat for other indication areas like asthma, COPD, depression and pain management.

“Over half of all smokers will attempt to quit each year,” Quigley says, “but the number one way they try to quit remains cold turkey -- because they’ve tried other therapies like patches and gums. They don’t deliver enough of the drug fast enough and at high enough levels to alleviate withdrawal symptoms.”

Current prescription products for smoking cessation also include pills like varenicline (Pfizer’s Chantrix brand) and Bupropion/Wellbutrin. An earlier inhalation device, Pfizer’s Nicotrol, was discontinued a couple of years back.

Nicotrol, notes Quigley, didn’t use a nebulizer to get the drug directly to the lungs. “When you puffed on it,” he explains,” it would deliver nicotine through the oral cavity, the same way that nicotine gum works.”

Other products, Quigley adds, are designed not to get people off nicotine entirely, but to lower their risk. These include “e-cigarettes and other platforms [e.g.,vaping] being advanced by tobacco companies.”

Quigley speaks from experience in this area, having served some seven years as CEO of Altria’s smokeless division prior to joining Qnovia in 2020.

“There are people who say ‘I need an alternative [to cigarettes] but enjoy using a nicotine product, and that’s where reduced-risk products come into play,” he says.

Nevertheless, the labeling Qnovia seeking from the FDA only targets its new therapy to smokers of traditional cigarettes who want to quit, Quigley says, adding that later on in the firm’s pipeline the company “will have opportunities to think of ways to expand the indication.” For example, “there will be vapers who want to stop vapings, who are dealing with cravings and withdrawal symptoms.”

Quigley says that Qnovia will submit its IND (Investigational New Drug application) to the FDA next month, allowing it to begin clinical trial, and hopes to have its formal NDA (New Drug Application) into the FDA in 2026.

He says it’s yet to be decided if Qnovia will commercialize the product on its own, or find a “partner like a pharmaceutical company that has a large sales force and the marketing capability.”

In either case, Quigley notes, Qnovia wants to make sure “that our therapy is broadly available and affordable because the smoking population today continues to be lower-income brackets, more rural, less education, including significant populations that are underrepresented.”  To reach them, he says, tobacco control centers and physicians will “need to be educated on how our medicine works and why it’s different.”