Tag: quitting

  • Tools to Quit

    Tools to Quit

    Credit: Qnovia

    The RespiRx, the first inhalable nicotine-replacement therapy, gains IND clearance.

    By VV staff

    A Virginia-based pharmaceutical company is developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform. Qnovia announced that its RespiRxNicotine Inhaler (QN-01) received clearance for its Investigational New Drug (IND) application by the U.S. Food and Drug Administration.

    The company will initiate a Phase 1, randomized, crossover, open-label trial in the U.S. to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes, according to Brian Quigley, CEO of Qnovia.

    “The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company. Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine-replacement therapies [NRTs],” said Quigley. “The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison.

    “We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission to the MHRA [Medicines and Healthcare products Regulatory Agency] in 2026.”

    Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to Mitch Zeller, the former director of the FDA’s Center for Tobacco Products, who is now serving as Qnovia’s policy and regulatory strategy advisor.

    “There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Zeller. “There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit.”

    Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, Quigley told Vapor Voice last year (“Licensed to Thrive,” Issue 1, 2023, page ?). Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG.

    RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal by-products.

    RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product.

    Credit: Qnovia

    “The nebulizing unit (cartridge) gets replaced by the patient every one [day] to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”

    Mario Danek, Qnovia’s founder and chief technical officer, agrees that eliminating the cleaning requirement was a priority. “The idea was to create a technology that emulates the form factor of a successful high-adoption consumer product but that is imbued with technologies that would pass CDER’s [Center for Drug Evaluation and Research] stringent standard for safety—combined with Qnovia’s purposeful design features, it should bring patient adherence and quit rates to new highs, which historically have been found lacking in NRT,” he said. “Additionally, from a drug delivery platform perspective, those CDER-aligned device safety requirements are just as imperative to Qnovia’s API expansion strategy into other indication areas.”

    RespiRx is a “step-down” therapy, like many NRT products. However, instead of buying different pods with varying levels of nicotine, Qnovia’s device has a dosage-monitoring system programmed into the device. Uniquely, the use regimen is determined based on how much a smoker is smoking, said Quigley. For example, a one-pack-a-day smoker would start with 20 doses per day. The two-pack-a-day smoker would start with 40 doses per day.

    “Then the device will, over the 12 weeks, gradually reduce the available number of doses to that patient. It is a much more manageable step-down over the 12 weeks, unlike currently available cessation methods. And the device itself will prevent the patient from using more than they’re supposed to use,” said Quigley. “Patients would also have the on-device LCD screen interface to help them understand how to use their doses. That, too, is another benefit of our product versus the existing smoking cessation therapies.”

    Danek said the company is proud to lead the charge in encouraging the innovation and development of safe and effective pharmacotherapies to help the millions of smokers who are trying to quit smoking.

    “We believe our proprietary drug delivery platform has the potential to be a highly differentiated treatment option not only for treatment of nicotine dependence but for a wide variety of treatments that would benefit from inhaled drug delivery,” said Danek.

  • Study: Vape Products Among ‘Top 3’ Quitting Aides

    Study: Vape Products Among ‘Top 3’ Quitting Aides

    Photo: Vadzim

    E-cigarettes are among the Top-3 most effective tools to stop smoking, according to a new review of evidence by a team of scientists. The other strategies are Varenicline, a prescription drug sold under brand names such as Chantix and Champix, and Cytisine, a plant-based compound sold as an over-the-counter natural health product in Canada and throughout central Europe and eastern Europe, and available under prescription in the United Kingdom.

    These tools for quitting work best when combined with behavioral support, such as counseling, according to the authors. Bupropion and nicotine replacement therapy (NRT) are also effective, especially NRT patches combined with fast-acting forms like gum.

    “For behavioral support, evidence is strongest for counseling and for programs that reward people for stopping smoking,” said senior author Jamie Hartmann-Boyce, assistant professor of health policy and management in the UMass Amherst School of Public Health and Health Sciences, in a statement.

    Published Sept. 4 in the journal Addiction, the review was conducted by the non-profit Cochrane Tobacco Addiction Group (CTAG)

    CTAG’s summary outlines the key findings from 14 Cochrane reviews that CTAG published between 2021 and 2023.

    The latest Cochrane review of e-cigarettes for smoking cessation concluded that there was high‐certainty evidence that e-cigarettes with nicotine increase quit rates compared with NRT, and moderate‐certainty evidence that they increase quit rates compared with e-cigarettes without nicotine.

    The 2023 Cochrane review of pharmacological and e-cigarette interventions for smoking cessation included all drugs licensed as treatments for smoking cessation anywhere in the world, as well as e-cigarettes with or without nicotine. The review included 319 studies (157,179 participants). The most effective interventions were nicotine e‐cigarettes, varenicline and cytisine, all of which had high-certainty evidence, closely followed by combination NRT. 

  • Study: Vapes ‘Twice as Effective’ to Quit Smoking

    Study: Vapes ‘Twice as Effective’ to Quit Smoking

    The American Consumer Institute (ACI) unveiled a study that provides a pivotal analysis of the potential for tobacco harm reduction alternative products, such as vaping and modern oral, to significantly reduce smoking-related deaths across the United States.

    Key findings from the study entitled “Transition from Tobacco to Vaping: The Health Impacts by State” by ACI Senior Policy Analyst Justin Leventhal, include:

    • A potential reduction of nearly 300,000 smoking-related deaths annually if e-cigarettes replace traditional smoking nationwide.
    • An estimated four million lives could have been saved from 2010 to 2024, surpassing deaths from the Coronavirus by a factor of four.
    • State restrictions and regulatory barriers on vaping products have been identified as significant obstacles for smokers seeking to quit, thereby increasing the annual death toll from smoking-related diseases.
    • Removing regulatory barriers on vaping products would enable a smoother transition for smokers toward safer products or kicking the habit entirely, potentially saving hundreds of thousands of lives each year.

    “Evidence suggests that e-cigarettes are nearly twice as effective as traditional nicotine replacement therapies like gums and patches in aiding smoking cessation,” a press release states. “Despite this, recent years have seen an increase in regulations, taxes, and outright bans on vaping products, hindering the progress toward a smoke-free future.”

    ACI calls for policymakers to reconsider these restrictive measures and focus on harm-reduction strategies that offer a pragmatic approach to reducing smoking-related mortality rates. By embracing tobacco harm reduction products as viable alternatives to smoking, states can significantly lower healthcare costs and mortality rates associated with tobacco use.

  • EU Parliament Endorses Vaping to Help Quit Smoking

    EU Parliament Endorses Vaping to Help Quit Smoking

    Credit: Ronstik

    The European Parliament, in full assembly, adopted a report recognizing the role of vaping in aiding smoking cessation. This comprehensive adoption by the Parliament marks a pivotal moment in the fight against smoking-related illnesses, according to an emailed World Vaper’s Alliance release.

    The report, a part of the Parliament’s broader initiative on non-communicable diseases, acknowledges vaping as an effective method for smoking cessation and may also set a new direction for health policies within the EU.

    The move follows the EU’s Subcommittee on Public Health (SANT) endorsement on Nov. 7. However, the initial recommendation by the SANT to limit vaping in certain public areas remains a point of contention.

    Michael Landl, director of the WVA, said the full adoption of the report by the Parliament is a step forward and underscores a significant shift in recognizing vaping’s positive impact on public health.

    “We now call on the European Commission to align with this perspective, as it represents the collective voice and decision of the Parliament, the direct representatives of EU citizens,” he said. “Listening to this voice is not just a matter of policy but of democratic responsibility.

    “While we welcome the Parliament’s endorsement, the proposed restrictions on vaping in public spaces are concerning. Such measures could inadvertently hinder smokers’ transition to a less harmful alternative.”

  • CBD Could Potentially Help Smokers Quit Smoking

    CBD Could Potentially Help Smokers Quit Smoking

    Cannabidiol (CBD) could help tobacco users quit, according to a new study published in Chemical Research in Toxicology.

    Washington State University researchers tested the effects of CBD and its major metabolite on human liver tissue and cell samples and found that it inhibited a key enzyme for nicotine metabolism. Slowing nicotine metabolism could allow users to wait longer before feeling the need for more. More research is needed, but according to Philip Lazarus, Washington State University professor of pharmaceutical sciences, the findings are promising.

    “The whole mission is to decrease harm from smoking, which is not from the nicotine per se but all the carcinogens and other chemicals that are in tobacco smoke,” said Lazarus, senior author of the study. “If we can minimize that harm, it would be a great thing for human health.”

    “It appears that you don’t need much CBD to see the effect,” said Lazarus.

    Lazarus’ team is developing a clinical study to examine the effects of CBD on nicotine levels in smokers, measuring nicotine levels in their blood versus smokers taking a placebo over the course of six hours to eight hours. They hope to then do a much larger study looking at CBD and nicotine addiction.

  • US Science Council Cries Foul on Cessation Study

    US Science Council Cries Foul on Cessation Study

    A recent study that found that vaping doesn’t prevent smokers from relapsing to cigarettes has a major flaw, according to Cameron English, writing for the American Council on Science and Health. The results seem to undermine the efficacy of e-cigarettes as smoking-cessation tools—”until you take a closer look at the definition of relapse.”

    At first glance, the study seems to undermine the case for e-cigarette use as a smoking cessation tool. But first glances, as we all know, rarely tell the whole story, according to English. A closer look at the paper indicates that its authors improperly assessed how smokers utilize e-cigarettes, thus generating results that don’t reflect reality.

    The researchers analyzed data on 3,578 previous-year smokers who had recently attempted to quit and 1,323 recent former smokers from the Population Assessment of Tobacco and Health (PATH) Study between 2017-2019. Participants self-reported their use of e-cigarettes or other products to quit cigarettes. The researchers then investigated who among the study participants had abstained from smoking or any tobacco products in 2019.

    Credit: Aleksej

    “The significance of this study is limited by the same flaw we found in an earlier paper by two of the same authors: relapse to tobacco use was measured by the question ‘In the past 12 months, have you smoked a cigarette/(used product), even one or two puffs/times?’ Using this metric, an individual who has almost entirely quit smoking, save for “even one or two puffs” of a cigarette, and someone who has gone back to smoking a pack a day would be counted as having relapsed,” English writes.

    “This definition ignores the fact that many smokers gradually switch from combustible cigarettes to their electronic counterparts. This is known as ‘dual-use,’ and properly designed epidemiological studies (even those based on PATH data) and clinical trials try to account for this behavioral shift, correctly noting that replacing even some cigarette smoking with vaping is desirable because vaping is the far safer option.”

    Additional high-quality research would be very helpful, but “preventing relapse” is an all but useless outcome, states English. “Unless the researchers evaluate how e-cigarettes are used in the real world, the only thing their next paper will confirm is that asking the wrong question inevitably leads to the wrong answer, he writes.

     

  • Study Claims Patches Better Than Vapes as Quit Aids

    Study Claims Patches Better Than Vapes as Quit Aids

    Credit: kues1

    A new study claims that those using e-cigarettes to quit smoking found them to be less helpful than more traditional smoking cessations aids such as patches and gum.

    The study, published Monday in the journal BMJ, analyzed the latest 2017 to 2019 data from the Population Assessment of Tobacco and Health (PATH) Study, which follows tobacco use among Americans over time.

    “This is the first time we found e-cigarettes to be less popular than FDA-approved pharmaceutical aids, such as medications or the use of patches, gum, or lozenges,” said John Pierce, the director for population sciences at the Moores Cancer Center at the University of California, San Diego, according to CNN.

    A three-month randomized trial in the United Kingdom, published in 2019, found e-cigarettes, along with behavioral interventions, did help smokers quit tobacco cigarettes. In guidance published in late 2021, the UK National Institute for Health and Care Excellence decided to recommend that smokers use e-cigarettes to help them quit.

    Another recent study, published in JAMA Network Open, found adult smokers with no plans to quit are more likely to stop smoking if they switch to daily vaping, according to new research led by Roswell Park Comprehensive Cancer Center.

    The Roswell Park study also used data collected from 2014 to 2019 as part of the PATH study. 

  • Vaping Boosts Quit Rate in Smokers Not Aiming to Quit

    Vaping Boosts Quit Rate in Smokers Not Aiming to Quit

    Photo: pioneer111

    Adult smokers with no plans to quit are more likely to stop smoking if they switch to daily vaping, according to new research led by Roswell Park Comprehensive Cancer Center.

    Published in JAMA Network Open, the Roswell Park study used data collected from 2014 to 2019 as part of the Population Assessment of Tobacco and Health Study (PATH). When the researchers focused their analysis on a select group of 1,600 smokers who initially had no plans to quit and were not using e-cigarettes when the study began, they found that those who subsequently vaped daily experienced eightfold higher odds of quitting traditional cigarettes compared to those who didn’t use e-cigarettes at all.

    “These findings are paradigm-shifting, because the data suggest that vaping may actually help people who are not actively trying to quit smoking,” says Andrew Hyland, chair of health behavior at Roswell Park and scientific lead on the PATH study, in a statement. “Most other studies focus exclusively on people who are actively trying to quit smoking, but this study suggests that we may be missing effects of e-cigarettes by not considering this group of smokers with limited intention to stop smoking—a group that is often at the highest risk for poor health outcomes from cigarette smoking.”

    Overall, only about 6 percent of all smokers included in the Roswell Park study quit smoking combustible cigarettes completely, but the rates of quitting were significantly higher among those who took up daily e-cigarette use—28 percent of smokers quit when they started vaping daily. The association between vaping and cigarette quitting held up even after adjusting for underlying characteristics such as educational background, income, gender, ethnicity and the number of cigarettes smoked per day at the beginning of the study.

  • VPZ Launches AEQ Pod Device Kit in U.K. Stores

    VPZ Launches AEQ Pod Device Kit in U.K. Stores

    A new pod device has been launched by the largest vapor retailer in the U.K. VPZ’s AEQ Pod Device Kit has been designed and developed in VPZ’s purpose-built facility in Edinburgh to support smokers looking to make the switch to vaping, according to a press release.

    Credit: VPZ

    “The device is an easy-to-use new to vaping product which offers smokers the freedom to choose a range of flavors and e-liquid strength,” the release states. “The AEQ is already outselling other packages in the new to vaping category and has been introduced as VPZ launches its first ever Vape Clinic.”

    Doug Mutter, director of VPZ, said VPZ is spearheading the fight against the U.K.’s No. 1 killer: smoking. “The Pandemic has triggered an increase in smoking rates and the public health problem has been compounded by funding cuts for NHS stop smoking services and local support groups,” he said. “The launch of our new AEQ device has been developed by us in response to helping smokers take the first steps in their stop-smoking journey. The development of this dedicated new to vaping product, as well as the launch of our pilot Vape Clinic truly underlines our commitment to helping the UK achieve its ambitions to be a tobacco-free nation by 2030.”

    VPZ is the UK’s largest vaping retailer with over 150 stores. A new report from Royal College of Physicians Tobacco Advisory Group backs vaping as an effective treatment for tobacco dependency and recommends that it should be included and encouraged in all treatment pathways. The report also found that the long-term impact of vaping is 95 per cent less harmful than smoking cigarettes.

  • Group Launches Platform for Vapers to Share Quit Stories

    Group Launches Platform for Vapers to Share Quit Stories

    The Canadian Vaping Association (CVA) has launched vapersvoice.ca, a national initiative that provides adult vapers a platform to share their story on how vaping helped them quit smoking. The aim of the initiative, sponsored by Flavourart Distro, is to remind Canadians and regulators that punitive vape regulation has real consequences for adult smokers that have chosen vaping to reduce their harm.

    Credit: Tumisu

    The website will enable adult vapers to upload short videos detailing, where they live, how long they smoked, how long they have been smoke-free, the flavor and nicotine concentration they used, and what they would do if flavors were to be banned. Canadian’s need to hear from adult vapers, not the industry. The CVA encourages all adult vapers to share their story, according to a press release.

    “Globally, the conversation around vaping has lost sight of the millions of lives that can be saved through vaping. Vaping has presented an unparalleled harm reduction opportunity and flavors are the key to adult adoption and success quitting smoking,” the release states. “Vapersvoice.ca will highlight the importance of flavored products and the positive impact vaping has had on the lives of millions of adult smokers.