Brian Quigley on New Nicotine Replacement Therapy Technologies

Author(s): Scott Douglas Jacobsen

Publication (Outlet/Website): The Good Men Project

Publication Date (yyyy/mm/dd): 2024/10/30

Qnovia received FDA clearance for its Investigational New Drug (IND) application for RespiRx™ Nicotine Inhaler (QN-01), an innovative nicotine replacement therapy (NRT). A Phase 1 trial will assess its safety and effectiveness. CEO Brian Quigley highlights its potential to revolutionize smoking cessation and other treatments. 

Scott Douglas Jacobsen: Today, we are joined by Brian Quigley, CEO of Qnovia, to discuss the RespiRx nicotine inhaler, also known as QN-01. With FDA clearance now obtained and clinical trials on the horizon, what inspired the development of this particular technology? Could you walk us through that process? Is this the only product the company offers?

Brian Quigley: Great! I’m excited to be speaking with you today. Qnovia is a company focused on developing a portfolio of inhaled therapeutics across various therapeutic areas. We are based in Richmond, Virginia. The core inspiration for our work stems from the technology behind what I’m holding right now—our device, the RespiRx. It is a handheld, portable nebulizer with a drug-filled cartridge. Nebulization has been used to safely deliver medicines via inhalation for decades.

We chose to focus on smoking cessation as our initial area of emphasis. On a personal note, my father was a lifelong smoker. He smoked for 50 years and tried to quit every year, using every combination of available therapies, but he was never able to successfully stop. The troubling reality is that millions of smokers are in the same situation. In the U.S., for example, there are approximately 28 million smokers, and more than half try to quit each year. Yet, the most common method they use is quitting cold turkey.

Why is that? Because the medications available to help them quit are outdated—most are over 20 years old. There has been little innovation in developing new treatments to help smokers quit, and the available options are largely ineffective. Our device aims to change that. RespiRx is a nicotine replacement therapy that delivers nicotine in an aerosol, allowing it to be inhaled into the lungs. This offers real advantages in terms of the speed and dosage of nicotine delivered, helping to alleviate cravings and withdrawal symptoms that smokers experience when attempting to quit. That’s a bit about the inspiration and the core technology behind what we’re doing.

Jacobsen: When going through FDA trials, people often wonder: How long do they take? How rigorous are they? What is the rejection or rerouting rate for new products?

Quigley: One positive aspect is that the public can trust that regulators ensure the safety and efficacy of the medicines that reach them. That’s the good news.

The challenge for a small company, however, is the significant time and financial investment required to meet the two critical thresholds for regulatory approval: safety and efficacy. At Qnovia, opening the IND (Investigational New Drug) application with the FDA means they have reviewed our initial safety data, as well as our device data on performance, controls, and compliance, and have deemed it safe to proceed with human clinical trials. However, there are three phases of clinical trials that need to be completed with the FDA.

Phase 1 focuses on demonstrating safety, tolerability, and getting a preliminary understanding of drug delivery in the body. That’s what we’ll be completing in our Phase 1 study. Phase 2 will involve approximately 100 subjects and will examine different dosing regimens and usage patterns to assess both tolerability and efficacy. Finally, the Phase 3 pivotal efficacy study generates the data that will be submitted as part of our New Drug Application (NDA) for FDA approval. In total, this process represents about four years of work and tens of millions of dollars invested in bringing the drug to market.

What’s interesting is that we’re advancing this technology in both the U.S. and the U.K. We’re doing this because the U.K. has a different mindset regarding how to demonstrate safety and efficacy for new smoking cessation medicines. They’ve created a pathway that, while not fast, cheap, or simple, is more streamlined and has clinical requirements that are easier for us to fund and execute. It takes less time and money compared to the U.S. However, our approach with any regulator we engage with is to address what they want to see, and our goal is to generate that data to ultimately get approved. That’s how we help save lives at the end of the day. So, in the U.S., we still have a lot of work to do. But the fact that we’re the first truly inhaled smoking cessation medicine to enter clinical trials is an important milestone.

We’ve already generated our first “first-in-human” data outside of the U.S., which gives us confidence in what our Phase 1 study will demonstrate. We are committed to continuing down this path to get this technology into the hands of smokers who want to quit.

Jacobsen: Would you consider the biggest hurdles to be in advancing this type of technology? As you mentioned, it’s been a long time since there was an update in this area, and smokers, who represent one of the largest groups struggling with addiction, are significantly impacted.

Quigley: The biggest hurdle lies in how regulators define efficacy. When it comes to drug development, the most common question I get asked is: “What endpoint do we need to show to get regulatory approval?” For smoking cessation, the endpoint is to use the medicine for 12 weeks as part of a step-down therapy. The FDA wants to see not only complete abstinence during those 12 weeks but also for 52 weeks after stopping the medication.

When you think about complete abstinence from addiction over 52 weeks, it’s incredibly difficult to achieve. Quitting smoking is extremely hard. If a person relapses, even with just one cigarette, it counts against us in demonstrating efficacy, and that’s a high bar. It’s achievable, but it is a very high standard.

What’s also interesting is that last year, the FDA published guidance to drive innovation in treating stimulant use disorders, such as methamphetamine and cocaine addiction. In that guidance, they proposed endpoints, including a reduction in the number of days someone uses these substances as a measure of progress from a public health perspective. When you compare this to the requirements for demonstrating efficacy in smoking cessation, there seems to be a bit of a disconnect.

The status quo for smoking cessation medicine is that someone out there today is smoking 20 cigarettes—the deadliest consumer product ever made. That presents a significant opportunity. In fact, the FDA is having a public hearing on October 21st, and there I will be sharing my views to contribute to the conversation about what else can be done to promote innovation in cessation medicine. That’s a real example of some of the challenges we’re facing.

Again, our view is that we’ll do the work. We’re a venture-backed company, so we’ll raise the capital and fund the necessary studies. However, when comparing the U.S. clinical pathway to the U.K. pathway, the reality is that, despite being a U.S.-based company, this product will likely be approved and available to help smokers quit in the U.K. years ahead of when it will be approved in the U.S.

Jacobsen: Earlier in the interview, you mentioned being a smaller company, which can be a big hurdle in itself, especially financially, compared to larger companies when going through the FDA approval process, from safety to efficacy. How significant is that barrier for smaller companies?

Quigley: It’s a double-edged sword, honestly. The strength we have is that we’re nimble. We move quickly and don’t have a big bureaucracy to navigate. A big part of being effective in this space is constantly learning, generating new data, and adapting. From that standpoint, being a smaller company is actually an advantage.

That said, we have only five employees at Qnovia. We rely heavily on external resources, advisors, and consultants to help guide us when and where we need support. So, bandwidth is definitely a challenge for a small company like ours, as there’s only so much we can do at any one time. The good news is that will change. We plan to bring more people on board and expand the team, but it’s still a double-edged sword.

Jacobsen: How do you make a compelling pitch to venture capitalists to say, “I have a good product, please invest in me”?

Quigley: That’s a great question. The key to winning over venture capitalists is data. The way they evaluate any drug development opportunity is by looking at the potential patient population and assessing the risk. They want to see data you’ve generated, where you are in the regulatory process, and how much validation you’ve achieved. The more data and validation, the lower the risk and the higher the likelihood that you’ll actually get your medicine into the hands of the people who need it.

What’s interesting, and this is a challenge specific to smoking cessation, is that many people I talk to ask, “If this could have been solved, wouldn’t it have been solved already?” So, there’s sometimes a perception that it’s an old problem and, while it’s still an issue, people wonder if it’s really worthwhile to invest in it. Then they compare it to what’s trendy, like GLP-1 drugs.

Everyone wants to have the next Ozempic, and some people think we should put our money there. So, oftentimes, we find ourselves speaking truth to a massive need, but we’re fighting against what’s trendy from an investor’s perspective. The good news is that we have a strong and committed base of investors who have backed this company because they believe in the importance of ending the death and disease caused by combustible cigarette use. If you buy into that mission, then you invest in our company.

I liken investing to being an actor. You have to go to 100 casting calls to find the right director who believes in you. But they are out there, and that’s how we’ve been able to get to this point and how we’ll continue to move forward.

Jacobsen: What would you consider the strongest critique of the company and the product?

Quigley: One of the challenges or critiques we hear frequently is around the confusion created by reduced-risk tobacco products, such as e-cigarettes. People often ask, “How do we compete with e-cigarettes and other reduced-risk products? And why do we even need new medicine? Shouldn’t those be the answer?”

My response is that it’s a nuanced view, but my strong belief is that we’re different. Smokers, when they become health-conscious, need multiple options. Some may say, “I’m not ready to quit, but I don’t want to die,” and that’s where reduced-risk products like e-cigarettes play an important role. We don’t compete with that—it’s a different need state. However, without a doubt, there are millions of smokers who ultimately say, “I want to stop. I no longer want to be addicted, and I can’t do it.” They’ve tried every product, but they keep going back to cigarettes, and their goal is to fully quit. That’s where we come in.

There are a lot of interesting dynamics in this space, but the development of new medicines—true medicines—has been left behind and somewhat lost in the noise. We’re not here to compete with reduced-risk products. We’re a drug company, while those products come from tobacco companies. We’re doing something different. If the public health vision of a future without cigarette use is to become a reality, then there will need to be a variety of products, including cessation medicines, to make that happen.

Jacobsen: Why will this technology reach the U.K. market so much faster than the U.S. market?

Quigley: It all comes down to the clinical endpoints. In the U.K., they’ve taken a more progressive approach to promoting innovation in smoking cessation medicine. They were one of the first countries to publicly support the role that e-cigarettes could play in helping smokers quit.

The guidance they’ve created is designed to help companies like ours, as well as e-cigarette companies, pursue medicinal licensing in the U.K. to help people quit smoking. Ultimately, their clinical requirements are different. Where in the U.S. we have to go through Phase 1, Phase 2, and Phase 3 trials, in the U.K., there’s a single clinical study to be executed. The goal of that study is to demonstrate that the nicotine we’re delivering is lower than what’s delivered by a cigarette. The MHRA (Medicines and Healthcare products Regulatory Agency) has made the broad assumption that less nicotine than a cigarette means it’s safer, given that millions of people are smoking cigarettes today. So, by delivering less nicotine, we’re not introducing any new harm to society.

Efficacy, in this case, is defined by the relative increase in nicotine delivery compared to existing nicotine replacement therapies. The U.K. has taken a broader view of the public health need, simplifying the clinical studies required to get to market. That’s the biggest difference between the two regulatory pathways.

Jacobsen: What about accessibility in terms of personal finance? In the U.K., there’s a societal emphasis on equity in healthcare, while in the U.S., the focus is more on autonomy and privatized healthcare. With those different values and preferences, how do outcomes, provisions, access to healthcare systems, and available technologies change at the individual level? How does it affect consumers who want access to your product?

Quigley: That’s a great question. I would expect there to be some differences in how the product is tailored to fit the user population, considering preferences, the healthcare environment, and the perspectives of healthcare providers and stakeholders in the U.K. versus the U.S. I’ll give you an example: the NHS.

The National Health Service (NHS) in the U.K. has a robust infrastructure for stop-smoking treatments. In some of our early conversations with individuals from the NHS, they viewed this product as a step-down therapy. This means you start at a certain nicotine level, and the device controls how much nicotine you receive, gradually stepping down over time to help you fully quit.

The NHS highlighted an important consideration: one of the primary intervention points in the U.K. healthcare system for smokers is admission to a mental health facility. For example, if someone is admitted to a mental health facility, part of their treatment may include helping them stop smoking. Their concern was that stepping down too quickly could cause harm to a person in such a vulnerable state. Therefore, they expressed the need for more flexibility in how the medicine is delivered to different patient populations.

In the U.K., I can envision the device and its programmatic use as a medicine being more flexible, aligned with the feedback we receive from stakeholders in the public health system. This flexibility would be an important part of ensuring the product meets the needs of diverse patients, especially in settings like mental health facilities. That’s a big part of the work ahead.

The healthcare system and how patients interact with their healthcare providers are different between countries. For example, in the U.K., they’ve created a stop-smoking service program that runs through pharmacies. If I want to quit smoking, I can go to my pharmacy, where my pharmacist is trained to provide behavioral support and counseling for smoking cessation. If I meet with my pharmacist every week, I can get my medicine at no cost and receive that behavioral support, which is crucial for quitting. So, our medicine and its use must be designed and purpose-fit for how practitioners will engage with patients.

That’s a long way of saying that we are ultimately guided by what the patient population and healthcare environment look like in each geography. That informs what we need to do differently with the device.

Jacobsen: Thank you so much for your time today.

Quigley: No worries! It was great chatting with you. I appreciate it. It was great chatting with you. Great questions, by the way.

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