Tag: harm reduction

  • 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.

  • ‘Ireland’s Vape Tax Puts Smokers’ Lives at Risk’

    ‘Ireland’s Vape Tax Puts Smokers’ Lives at Risk’

    Photo: Taco Tuinstra

    Ireland’s new tax on e-cigarettes is a setback in the fight against tobacco, condemning thousands of smokers to unnecessary premature death, according to international health experts.

    This week, the Irish government announced a levy of €0.50 per ml of e-liquid as part of its annual budget, adding €1.23 to the cost of a typical vape. This tax is far above the European average of €0.10 to €0.30.

    “Sweden is on the brink of achieving smoke-free status as a result of its progressive approach to safer alternatives like vaping. This contrasts sharply with Ireland’s approach, where smoking rates remain four times higher,” said Delon Human, leader of Smoke Free Sweden, in a statement.

    “Sweden’s successful policies, including lower taxes on safer nicotine alternatives, have helped reduce smoking and smoking-related deaths. In stark contrast, Ireland’s new levy will discourage smokers from switching to less harmful options, potentially keeping them addicted to cigarettes and condemning them to unnecessary premature death.”

    According to a recent Irish public consultation, only 10 percent of respondents supported increasing taxes on vaping above the EU average, while 39 percent warned that higher prices would push consumers to source products abroad.

    Through the promotion of safer alternatives like snus, nicotine pouches and vapes, Sweden has reduced its smoking rates by 55 percent over the past decade, resulting in a staggering 44 percent fewer tobacco-related deaths compared to the rest of the European Union.

    “By raising taxes on safer alternatives, Ireland jeopardizes its hopes of reducing smoking rates,” Humans said. “If Ireland truly wants to cut smoking and save lives, it should follow Sweden’s lead in promoting harm reduction, not penalize smokers for trying to quit.”

  • Vape, Crypto Project PuffPaw Raises $6 Million

    Vape, Crypto Project PuffPaw Raises $6 Million

    Credit: Auremar

    An upcoming vape-to-earn project wants to use token incentives and blockchain-enabled vapes to make nicotine addictions additions go up in smoke.

    Called Puffpaw, the project intends to sell specialty vapes that record their user’s smoking habits on the blockchain. It will reward them in their tokens for gradually reducing their nicotine intake.

    Puffpaw is among a cadre of startups betting on the yet-to-launch Berachain blockchain, a venture capital darling.

    The quit-smoking project itself raised $6 million in seed funding led by Lemniscap Ventures. Lemniscap General Partner Shaishav Todi said the investment is a bet on decentralized physical infrastructure, commonly known as DePIN, according to Coindesk.

    “By building at the crossroads of culture and crypto and health, Puffpaw is making DePin accessible and practical, and has huge potential for mass adoption, particularly given increasing consumer demand for health-conscious vaping solutions,” Todi said in an email statement.

    Using token incentives to support healthier behavior isn’t new in crypto.

    Puffpaw’s leader Reffo Tse compared aspects of his gambit to StepN, a run-to-earn app on the Solana network.

    Puffpaw’s model attempts to create a self-supporting ecosystem of smokers who try and buy its products while weaning themselves of nicotine.

    Users can only take a certain number of puffs per day from their specialty vapes. They earn more tokens for taking hits of lower-nicotine level vape cartridges.

    They can then use those tokens to buy more vape cartridges from Puffpaw.

  • Study: Vaping as Effective as Chantix as Quit Aid

    Study: Vaping as Effective as Chantix as Quit Aid

    Credit: Brian Jackson

    E-cigarettes were just as effective as the gold-standard pharmaceutical drug varenicline, also known as Chantix, in helping people quit smoking, according to a clinical trial published Monday in JAMA Internal Medicine.

    A total of 458 daily smokers who were willing to quit were randomly assigned to one of three groups for a 12-week trial.

    One group received a nicotine-containing e-cigarette and placebo tablets, another group received varenicline and a nicotine-free e-cigarette, and the third group received a placebo tablet and a nicotine-free e-cigarette. All three groups also received extensive tobacco cessation counseling.

    After 26 weeks, approximately the same percentage of participants using varenicline and e-cigarettes, 43.8 percent and 40.4 percent respectively, had stopped smoking.

    The difference in quit rates between the two groups was not statistically significant.

    The JAMA study is the first published randomized controlled trial to directly compare varenicline to e-cigarettes.

    Previous studies have shown that e-cigarettes can help adults quit smoking. However, most of these studies have compared e-cigarettes either to a placebo or to nicotine replacement therapy, such as patches and lozenges, which help smokers manage their withdrawal symptoms.

  • U.K. Misleading Public on Relative Risk: Gilchrist

    U.K. Misleading Public on Relative Risk: Gilchrist

    Mora Gilchrist (Photo: PMI)

    Philip Morris International has accused the U.K. Department of Health of spreading misinformation about heated-tobacco products after a social media post warning that “all forms of tobacco are harmful,” reports The Grocer.

    A tweet posted by the department in a thread of “myths” about vaping and tobacco contained false and misleading statements and risks driving consumers back to cigarettes or dissuading current smokers from making the switch to alternatives, according to the multinational.

    “What hope do adult smokers have when seeking out accurate information on smoke-free products if it’s the government that’s spreading misinformation?” said PMI Chief Communications Officer Moira Gilchrist.

    “All forms of tobacco are harmful, and there is no evidence that heated-tobacco products are effective for helping people to quit smoking,” the tweet stated.

    “Laboratory studies show clear evidence of toxicity from heated-tobacco products. Unlike vapes, there is no evidence they are effective for helping people to quit smoking,” the post continues, citing a 2017 report by the Committee on Toxicity.

    According to Gilchrist, such statements “distort the scientific evidence base” and “seriously misleads the public.”

    While acknowledging that heated tobaccos are not risk-free, Gilchrist said it is misleading to imply that all forms of tobacco are equally harmful.

    A Public Health England report in 2018 said that available evidence suggested that heated-tobacco products “may be considerably less harmful than tobacco cigarettes” but “more harmful than e-cigarettes.”

    The Grocer

  • Study Finds States Differ in Harm Reduction Efforts

    Study Finds States Differ in Harm Reduction Efforts

    A new R Street Institute report found that while some states support one type of harm reduction, those same states may actively oppose another type of harm reduction. 

    The report, “Progressive Except for Nicotine: A Discussion of States’ Inconsistent Adoption of Harm Reduction Public Policy, examined the harm reduction policy landscape across tobacco, opioids and cannabis in all 50 U.S. states.

    Researchers identified several important harm reduction-related policies that have varying levels of acceptance/implementation across different states or are currently in legislative flux: tobacco: state and municipal restrictions on electronic nicotine-delivery systems; opioids: states’ authorization of syringe services programs, decriminalization of drug checking equipment, and presence of state-imposed restrictions on methadone that go beyond federal regulations; and cannabis: the legal status of medical and recreational adult-use cannabis markets in each state.

    Researchers then used this information to rank states as “restrictive,” “moderate” or “permissive” on harm reduction with regard to each substance. These rankings were quantitatively compared for all states, and states deemed “restrictive” on at least one substance were qualitatively examined. 

    The report also showed that the five states most restrictive of reduced-risk nicotine products in tobacco harm reduction are California, Massachusetts, New Jersey, New York and Rhode Island, and these states are relatively “permissive” when it comes to opioid harm reduction and cannabis use.

    The researchers have suggested that lawmakers reflect on the inconsistencies between harm reduction policies across substances and put political motivations aside to support harm reduction across all substances.

  • Study: Legal Marijuana States See Lower Tobacco Use

    Study: Legal Marijuana States See Lower Tobacco Use

    Credit: J Doms

    While some public health experts have expressed concerns that the legalization of marijuana could fuel a rise in the use of tobacco products, a new study instead concludes that state-level cannabis reforms are mostly associated with “small, occasionally significant longer-run declines in adult tobacco use.”

    Researchers did find “consistent evidence” that the adoption of state recreational marijuana laws (RMLs) led to a slight uptick in cannabis use among adults—of between about two and four percentage points, depending on the data source—but tobacco didn’t follow that trend.

    If the apparent substitution effect from cigarettes to marijuana that’s being driven by legalization were extended nationally, it could result in healthcare cost savings worth more than $10 billion per year, the study concluded, reports Marijuana Moment.

    “We find little empirical support for the hypothesis that RMLs increase the net consumption of tobacco, as measured across a wide range of combustible tobacco products as well as [e-cigarettes],” they wrote. “Rather, the preponderance of evidence points to small, occasionally significant longer-run declines in adult tobacco use.”

    Authors at Bentley, San Diego State and Georgia State universities published the findings in the Journal of Health Economics last month, calling the report “the first to comprehensively examine the impact of recreational marijuana legalization on tobacco use.” The study draws on federal data from the Population Assessment of Tobacco and Health (PATH) and the National Survey on Drug Use and Health (NSDUH).

    At a time of surging public support for cannabis legalization, the researchers write, “public health experts have taken a more cautious approach, urging more research to assess the health benefits and costs of marijuana use, as well as to understand potentially unintended consequences on other health behaviors.” Some have raised concerns that reform could lead to the “renormalization” of smoking, potentially reversing nearly half a century of declining cigarette use.

  • Researchers Condemn Medical Body’s Position on E-cigarettes

    Researchers Condemn Medical Body’s Position on E-cigarettes

    Colin Mendelsohn

    Australia’s National Health and Medical Research Council’s (NHMRC) statement on e-cigarettes fails to meet the scientific standard expected of a leading national scientific body, according to 11 addiction scientists, reports Medical Express.

    Published in June 2022, the NHMRC statement aims to provide “public health advice on the safety and impacts of electronic cigarettes (e-cigarettes) based on review of the current evidence.”

    This critique of the NHMRC statement, published in Addiction, argues that the statement inaccurately summarizes the current evidence on e-cigarettes. The authors contend that the NHMRC exaggerates the risks of vaping and fails to compare them with smoking;  incorrectly claims that adolescent vaping causes subsequent smoking; and ignores evidence of the benefits of vaping in helping smokers quit.

    The NHMRC statement also ignores evidence that vaping is likely already having a positive effect on public health and misapplies the precautionary principle, which requires policymakers to compare the risks of introducing a product with the risks of delaying its introduction.

    “Many leading international scientists in the field hold more supportive views than the NHMRC on the potential of e-cigarettes as a strategy to improve public health,” said Colin Mendelsohn, lead author of the Addiction article. “In particular, invoking the precautionary principle to prevent the use of much less harmful smoke-free products is unjustified in the face of the massive public health burden of smoking.”

  • Experts: Embracing THR Goals Reduces Smoking Rates

    Experts: Embracing THR Goals Reduces Smoking Rates

    The Asia Harm Reduction Forum 2021 attended by the leading experts in technology, public health policy and science met to discuss the tobacco harm reduction (THR) strategies deployed in various countries, according to a press release from the Canadian Vaping Association.

    “We have known the risks from smoking for many decades. We have known that it is the smoke, not the nicotine, that is responsible. We also know that we can deliver nicotine in ways that have minimal risk,” said David Sweanor, chair of the Center for Health Law, Policy and Ethics and an adjunct professor of law at the University of Ottawa. “As a result, Sweden’s rates of tobacco-related illness and death are by far the lowest that you can see in the European Union. Their smoking rates are now low enough that many people would call it a smoke-free society. When Norway allowed snus products to be more widely available, cigarette smoking fell by half in just 10 years. When Iceland allowed both vaping products and snus into the market, smoking fell by about 40 percent in just three years.”

    For decades, Canada has tried to curb smoking through education and taxation with limited success. Reductions in smoking prevalence had generally slowed, with modest annual declines prior to more mainstream adoption of vaping by smokers. Vaping experienced peak adoption in 2019, which lead to a 7.5 percent decline in cigarette sales.

    “Harm reduction is one of the four pillars of Canada’s drug and substances policy. Policy that makes vaping less appealing to smokers, like flavor restrictions and taxation, is out of step with this policy. In effect, Canada has embraced harm reduction in name but not substance,” said Darryl Tempest, Government Relations Council to the Canadian Vaping Association.

  • Another U.K. Community to Offer Free Vapes to Smokers

    Another U.K. Community to Offer Free Vapes to Smokers

    Credit: Oleksandra Voinova

    Smokers in England continue to be encouraged to quit by being offered free vaping devices. The action will now bring the borough of Kirklees in West Yorkshire, one step closer to fulfilling the UK government’s ambition for England to be smoke free by 2030, a move which could save local National Health Service (NHS) trusts millions of pounds.

    The devices are now available from Kirklees Council’s stop smoking services and the charity Yorkshire Cancer Research alongside more traditional forms of Nicotine Replacement Therapies such as patches or gum. The devices are being offered as part of the Kirklees Wellness Service, a council funded initiative that supports over-18 youth in Kirklees to live healthier lives.

    Stuart Griffiths, director of research, services and policy at Yorkshire Cancer Research, said his organization is committed to saving lives by helping more people quit smoking for good. “Yorkshire has the highest smoking rate in England, and this causes thousands of smoking-related cancers and needless deaths in our region each year,” he told Yorkshire Live. “When it comes to helping people quit for good, being able to offer vaping products is essential. They are an incredibly effective aid in helping people give up cigarettes.”

    A recent review of evidence by global researchers Cochrane has shown that vaping devices are more effective than Nicotine Replacement Therapy (NRT) when supporting smokers to quit. More than 500 people in Kirklees lose their lives to smoking related illnesses every year, yet smoking remains one of the biggest causes of preventable death in the region, according to the story.