A novel NRT for quitting smoking and vaping has been submitted to the UK medicines regulator for approval

Ventus Medical LTD announces that it has submitted a UK Marketing Authorisation Application for ENHALE™, a next- generation smoking cessation and harm reduction product which will give tobacco product users a safer alternative to both smoking and vaping.

ENHALE™ features a certified medical device and easily replaceable cartridges with novel and proprietary electronic inhalation technology. ENHALE™ meets the rigorous safety standards required of a medicinal product.

• ENHALE™’s proprietary formulation and low-temperature vaporisation technology ensure no thermal degradants and safer nicotine delivery than traditional vapes, an important differentiator from every other product.
• Obtaining UK MHRA approval is the first step in enabling healthcare professionals to prescribe for the first time, an effective vape-like product that is regulated and certified to be safe.
• When approved, ENHALE™ will be available without prescription in the UK.

Commenting on this submission, Kaasim Mahmood, Chairman of Ventus Medical and General Partner at Advent Life Sciences, said, “Smoking remains the most preventable cause of premature death globally. There is an urgent need for regulated, safer alternatives to vaping products and cigarettes. Advent Life Sciences is proud to have supported Ventus Medical, a UK company, on its journey to this important milestone. ENHALE™ has been designed and

developed following extensive consultation with physicians, healthcare professionals and smokers who require a medicinal alternative to tobacco products.”

David Lawson, co-founder of Ventus Medical, added, “After nine years of rigorous research and development, we have successfully developed aerosolization technology to the strictest standards meeting pharmaceutical and medical device requirements globally. Clinical data on ENHALE™ confirm it’s ability to reduce the urge to smoke by more than leading NRT’s. This is a great step forward for smoking cessation and tobacco harm reduction and will be the first innovation in NRT for decades.”

ENHALE™ features an intuitive, easy-to-use, certified medical device with replaceable single-dose nicotine cartridges. The product is unique in utilizing low-temperature vaporisation technology, which heats the nicotine formulation to much lower temperatures when compared to vape products. Operating at lower temperatures ensures that ENHALE™ can safely and effectively deliver nicotine without any thermal degradation or metals which are of particular concern in vaping products.

About Ventus Medical
Ventus Medical is dedicated to the development of inhalation technology and is a certified medical device manufacturer based in the UK. The founding team of Ventus Medical were responsible for the first and only approved medical vape product (e-VOKE), which was licensed in 2013 by the MHRA.

In the UK, statistics for 2019 show that 14.1% of people aged 18 and above smoke cigarettes. That’s around 6.9 million people.

The number of smokers has fallen in recent years, although quitting cigarettes is still a challenge with a low rate of success when people try to quit ‘cold turkey’.

It’s been proven that people who use NRT (Nicotine Replacement Therapy) products, along with other cessation aids that work for them, have the highest chance of successfully quitting.

In fact, it’s been proven that the chances of quitting smoking long-term increases by 50-60% when using NRT products.

How effective are NRT products in helping people quit smoking?

A study published by Cochrane detailed how 136 trials, which included 64,640 people in the main analysis, were performed into the effectiveness of NRT products as smoking cessation aids.

Trials lasted for six months, and participants were typically smoking at least 15 cigarettes a day.

The types of NRT products used were; gum, nasal and oral sprays, inhalers, patches, lozenges, and tablets. All of the NRT products that are generally used in the UK.

The results showed that all forms of NRT products made it more likely that a person was able to quit smoking. The increase in success rate over trying to quit without the aid of NRT was in the 50-60% range.

The study concluded by saying, “There is high-quality evidence that all of the licensed forms of NRT can help people who make a quit attempt to increase their chances of successfully stopping smoking.”

Why does NRT help people quit smoking?

The main reason why people smoke and find it hard to quit is because they are addicted to nicotine.

Nicotine is just one of the thousands of chemicals in cigarettes, but it’s the most addictive substance. Interestingly, nicotine is one of the least harmful chemicals used in cigarettes on it’s own.

This is why it’s fine for someone to use nicotine products, and why NRT products are so effective at helping someone quit smoking.

By using NRT, a person is able to maintain their intake of nicotine without any of the harmful chemicals found in tobacco products.

If someone does attempt to quit without using NRT, the chance of success is so much lower because they will experience withdrawal symptoms and cravings when they stop ‘cold turkey’.

It’s these withdrawal symptoms that leads to people returning to smoking tobacco. By using NRT and stopping the physical symptoms, it’s easier for a person to focus on the other aspects of their lives that may cause them to relapse.

NRT products are available in various strengths and can be used at different intervals throughout the day. To find a product and strength that will work best for you, you should consult a GP.

Conclusion

For more information on how inhaled nicotine can help you quit smoking more reliably, and safer, reach out to a member of our team for more details.

Resources

ons.com – Adult smoking habits in the UK: 2019

nhs.uk – Stop smoking treatments

McMaster University – Quitting Time: Does nicotine replacement therapy work?

Cochrane – Can nicotine replacement therapy (NRT) help people quit smoking?

It’s common knowledge that nicotine is the addictive substance in tobacco products that makes it hard for smokers to quit.

However, how much do you know about nicotine and its use in NRT products?

In this article, we’re looking at what nicotine is, how it’s manufactured, and how nicotine is being used in NRT products to help people quit smoking in a safe manner.

How nicotine is produced

The nicotine found in tobacco products is derived from tobacco plants, which are part of the nightshade family of plants. There are various species of tobacco plants, the scientific name for the type of nicotine used in tobacco products is Nicotiana tabacum.

Nicotine can actually be manufactured in two ways – it’s either extracted from the tobacco plant, or it’s produced synthetically.

Synthetic nicotine or ‘tobacco-free nicotine’ is a man-made substance. It can be produced in several ways but is typically regarded as having no real differences from nicotine extracted from tobacco plant leaves.

Why Use NRT Products?

Nicotine is the main active ingredient in tobacco products that cause users to become addicted. However, it’s the other chemicals in tobacco products that are harmful, not nicotine on its own.

When someone tries to quit smoking, typically they will experience withdrawal symptoms and cravings. These cravings are signals from the brain indicating that the body is missing nicotine.

It’s known that only around 3 of every 100 people who attempt to quit smoking ‘cold turkey’ do so successfully. This number increases by 50-60% when using NRT products as a smoking cessation aid.

Most of this success is related to the fact that NRT products help users keep cravings and withdrawal symptoms at bay. Without the overwhelming desire to use a tobacco-related product, the user can move on to NRT products and slowly taper off their use.

How nicotine is used in NRT products

Here is a look at how nicotine is used in some of the most popular NRT products:

Nicotine gum – Nicotine gums are not chewed like regular gum. They are chewed intermittently and held in the mouth for a recommended duration based on the strength.

Gums are typically available in 2 and 4 mg dosage forms. They are designed to release nicotine into the body slower than cigarettes and at the user’s discretion.

Nicotine patches – Nicotine patches contain a large amount of nicotine and are designed to release nicotine slowly and continuously for several hours a day.

Patches are one of the most popular NRT products as they are discrete and slowly release nicotine over long periods.

Nicotine inhalers deliver nicotine in a way most similar to that of smoking and many smokers prefer this method of delivery when quitting smoking.

Conclusion

To learn more about nicotine replacement therapy and how these products are developed and regulated, get in touch to speak with a member of the team.

Resources

MedicalNewsToday.com – Everything you need to know about nicotine

NHS.uk – Coping with cravings

Cochrane – Can nicotine replacement therapy (NRT) help people quit smoking?

V2 – What is Synthetic Nicotine and is it safe?

ncbi.nlm.nih.gov – Nicotine Replacement Therapy: An Overview

If you’re planning on quitting smoking and have done some research into the most effective and reliable ways, you will have heard that NRT (nicotine replacement therapy) has the highest success rate.

Statistically, using NRT or other forms of inhaled nicotine is the safest and most reliable way to quit smoking.

What isn’t often talked about, is some of the positive effects nicotine can have on the body.

It’s common knowledge that nicotine is the addictive chemical in cigarettes. By continuing to supply the body with nicotine – without all the other harmful chemicals in cigarettes – you can leave smoking behind you.

In addition to this, here are some of the science-backed benefits of continuing to use nicotine as you quit smoking:

Nicotine can improve cognitive functions

Smoking has a negative effect on cognitive functions. It’s known to increase the risk⁽¹⁾ of developing Alzheimer’s disease, dementia, and generally harms cognitive functions such as attention span, brain function, working memory, and more.

It’s not known exactly which chemicals or the combination of which chemicals are responsible, but it’s not nicotine.

In fact, studies have shown that nicotine has the opposite effect on cognitive functions. One of the more recent and lengthy studies carried out in 2018⁽²⁾ concluded:

“Preclinical models and human studies have demonstrated that nicotine has cognitive-enhancing effects, including improvement of fine motor functions, attention, working memory, and episodic memory.”

Nicotine helps improve sleep and mood

When/if you were smoking you will have been very familiar with how it disrupts regular sleeping patterns. Which, in turn, causes all the ill-effects that accompany getting a lack of quality sleep. 

The harmful chemicals in cigarettes also raise the risk of developing long-term sleeping conditions, such as sleep apnea, insomnia, and snoring.

Another interesting effect nicotine has on the body is that it’s a stimulant, but also has a mood-modulating effect⁽³⁾.

There may be an adjustment period when you first quit smoking but taking nicotine therapy is going to have a positive impact on your mood and sleeping habits. Essentially, you are going to feel more alert during the day, and able to sleep better at night.

Nicotine stops ‘cold turkey’ cravings

Quitting smoking is difficult, the facts back this up. It’s estimated that about 60%⁽⁴⁾ of smokers in the UK want to quit, but only about 6%⁽⁴⁾ are able to successfully quit. 

The main reason why most people fail to quit is due to the overwhelming withdrawal symptoms⁽⁵⁾ they experience. Which is essentially the body craving a cigarette, or more specifically, nicotine.

Typical withdrawal symptoms include:

• Loss of appetite
• Feeling sick, dizzy, experiencing headaches
• The need to fidget and keep hands busy
• Feeling tired, run-down, or mentally fatigued

Withdrawal symptoms manifest because nicotine is an addictive chemical. When a person quits smoking and the body stops getting nicotine, the brain sends out signals in the form of withdrawal symptoms.

It’s at this point people have the choice between smoking or using NRT to satisfy the brain and stop the withdrawal symptoms.

Nicotine on its own is not harmful. Hence, using NRT to quit smoking is the safest and most reliable way to quit cigarettes for good.

Conclusion

If you’re in the process of quitting smoking, using NRT or inhaled nicotine is known to have the highest chance of success. It’s also the safest option and offers the benefits discussed above.

To learn more about inhaled nicotine and how they can help you quit smoking in a safer, and more reliable way, get in touch to speak with a member of the team.

References

1. Yuko Hara, PhD (2016) Your Brain is Begging You: Stopping Smoking

2. 2018 May; 16(4): 403–414 Cognitive Effects of Nicotine: Recent Progress

3. 2018 Henry Ford Health System The Link Between Sleep And Nicotine

4. GOV.UK One person quits smoking every 80 seconds in England

5. Smokefree.gov Why Quitting is Hard

New research has shown there is a stronger connection between inhaled nicotine and quitting smoking than previously thought. Or, at least a stronger connection than what has previously been shown through the limited study data available.

In a recent study published as an editorial in JAMA by Nancy Rigotti, MD, director of the Tobacco Research and Treatment Center at Massachusetts General Hospital this October.

Rigotti (2020) and several of her colleagues published a review of 50 studies on the Cochrane Library. The purpose of these studies was to evaluate the safety of using inhaled nicotine, and how effective they were in helping long-term smokers quit.

More than 12,430 adult smokers took part in a series of controlled trials, one of the largest collections of studies in its class. In these studies, a number of smokers were randomised to inhaled nicotine, and the duration in which they quit smoking was monitored.

In summary, the studies showed that there was “moderate-certainty evidence” that quit rates in smokers were higher in those who were given inhaled nicotine as a replacement to smoking.

Why is this important?

Any new studies into safer ways for smokers to quit are valuable data. More than 8 million people die as a result of smoking globally every year.

The global impact, both directly on the health of smokers, and the financial implications individually and on health services around the world is immense

According to a survey carried out in 2015, about 70% of smokers in the United States wanted to quit. Out of that 70%, about 55% actually attempted to quit. From that 55%, only 7% were successful in their efforts to quit for a period of at least 6 months.

We know that the main reason why most people fail to quit is because of the withdrawal symptoms, stress, and weight gain. All of which are tied to going “cold turkey” or not using cessation aids that contain nicotine.

Rigotti (2020) and her team see inhaled nicotine as a new option to help smokers quit. As they contain nicotine, of which the amount a person is inhaling can be controlled, there are few to no withdrawal symptoms.

In addition to this, they do not burn tobacco as cigarettes do. This means the users are not inhaling harmful toxin-filled smoke – neither are they having a negative effect on those around them with passive smoke.

In conclusion

From the results of the 50 studies, Rigotti (2020) and her team concluded FDA-approved therapies should be the first choice for patients wanting to stop smoking.

They present the safest option we currently have, with the highest chance of success.

To learn more about inhaled nicotine and how they can help you quit smoking in a safer, and more reliable way, get in touch to speak with a member of the team.

With the coronavirus pandemic having such a huge impact on the health and wellbeing of the global population, we’ve been overwhelmed with health-related information this year.

As smoking is already one of the leading causes of death killing more than 8 million globally every year, it’s no surprise that the impact of smoking on the coronavirus has come under the spotlight.

There has been some conflicting information over the last few months. This is not unexpected. As more data is collected across more geographic, a better picture of the health effects of smoking and the coronavirus is becoming clear.

Here’s what we do know at this point according to the World Health Organization and the Centre for Tobacco Control Research and Education at the University of California:

The effect of smoking if you have COVID

Studies have shown that if someone has COVID, smoking makes the effects of the disease much worse. Both in the rate at which symptoms worsen, and the overall severity of the disease.

When someone has the flu or another infection of the lungs, smoking worsens their symptoms. It’s no surprise therefore that the same applies if a smoker has COVID, as this disease also affects the lungs.

It’s also believed that smoking increases the risk of being infected and developing COVID. So, there are two negative implications to one’s health if they use tobacco-related products; both an increased risk, and the severity of the disease.

There were some early studies that stated cases of COVID infections were lower among smokers than nonsmokers. This has since been proven to not be true.

The problem was that those studies were carried out on small numbers of people, and in particular, were being carried out on patients being tested for COVID, not the general population.

This has since been readdressed. Jing Cheng from the Centre for Tobacco Control Research and Education said new studies have proven that smokers had double the chance of disease progression if they already have COVID.

Why smokers are at higher risk of COVID progression

Smoking is associated with (ARDS) Acute Respiratory Distress Syndrome, a life-threatening condition where the lungs cannot provide the body’s vital organs with enough oxygen.

COVID is a disease that causes mild to moderate respiratory illness. As smoking lowers a person’s respiratory immune function, there is an obvious connection between smoking and COVID progression.

Smoking is also a risk factor for cardiovascular disease, cancer, respiratory disease, and diabetes. All of these conditions also put people at higher risk of developing illness when infected by COVID.

What can you do to protect yourself?

The only real solution to protecting yourself against COVID, outside of all the regular government advice, is to quit smoking.

Your lungs are not going to repair overnight. In fact, depending on how long you’ve been smoking, you may deal with smoking-related illnesses for the rest of your life.

Your health will improve after you quit, however. For most people, their lungs will start to heal when they’ve stopped smoking. You will also see a marked improvement in other health-related areas, such as improved breathing, you’ll have more energy, be able to think clearer, and lots more.

In addition to this, you will not be as high of a risk of developing COVID, and your immune system will be stronger to fight off the virus.

To learn more about the impact of smoking on the coronavirus, other smoking-related illnesses, and safer options for quitting smoking, get in touch to speak to a member of the team.

Smoking tobacco is widely acknowledged as the leading cause of illness and death across the globe.

It’s estimated that more than 7 million people die each year due to smoking-related illnesses. According to the NHS, every year around 78,000 people die in the UK alone from smoking-related illnesses, and thousands more live with debilitating smoking-related illnesses.

These statistics are not limited to smokers themselves. Smoking also passively affects family members, and on a wider scale the general public.

Of the 7 million that die each year, it’s estimated that around 884,000 of those deaths were due to secondhand smoke.

The Tobacco Harm Reduction (THR) public health strategy

The concept of Tobacco Harm Reduction actually dates back to at least 1976. A Professor by the name of Michael Russell published a medical article stating, “People smoke for the nicotine but they die from the tar.”

It’s been known for a long time that nicotine is the addictive chemical in tobacco-related products.

It wasn’t until more recent years, however, that large steps forward have been made to help reduce the number of smokers, the appeal of starting to smoke, and effective smoking cessation devices started entering the market.

Effective Tobacco Harm Reduction products

Nicotine Replacement Therapy (NRT) products

One of the most effective smoking cessation products to enter the market has been Nicotine Replacement Therapy (NRT) products.

The main reason most people smoke, and certainly the main reason for people failing to quit, is because they are addicted to nicotine.

Nicotine is the chemical that gives smokers that “hit”, or a satisfied feeling. It’s also the withdrawal from this chemical that causes most of the withdrawal symptoms smokers experience when trying to quit.

NRT products are designed to supply the user with nicotine, without the hundreds of other more harmful chemicals in cigarettes.

They are available in various forms. Such as inhalers, gums, patches, and nasal sprays.

E-cigarettes

E-cigarettes come in various shapes and sizes. The general idea behind them is to simulate the feel of a cigarette and/or supply nicotine, without supplying most of the harmful chemicals tobacco-related products contain.

Also known as Vape Pens and Electronic Nicotine Delivery Systems (ENDS), e-cigarettes still contain some chemicals.

The chemicals a user inhales varies depending on the “e-juice” they’re using. But most of the harmful chemicals found in cigarettes, such as carbon monoxide are not present.

Users have a good deal of flexibility when choosing and using an e-cigarette. It’s also an effective way to help smokers quit and the present less danger to the general public.

Why is Tobacco Harm Reduction important?

The World Health Organization (WHO) made a public statement that sums up the ripple effect smoking has on the health of the general public:

“Every person should be able to breathe tobacco-smoke-free-air.”

It’s not just a smoker’s health being compromised when smoking tobacco. They are also releasing dangerous airborne chemicals that can stay in the air for several hours and travel up to 20 feet.

We all have a duty of care when it comes to affecting the health of others though our own actions.

If you want to learn more about the overall Tobacco Harm Reduction public health strategy, or more specifically, what we’re doing here at Ventus Medical to develop safer NRT devices, please contact us and a member of our team will be happy to talk to you.

There has always been anecdotal evidence and the general assumption that people who are lonely are more likely to smoke, and vice versa.

However, until recently there had been little scientific research into the direct correlation between smoking and loneliness.

This is why a recent study carried out by the University of Bristol has piqued the interest of many. The study involved using the genetic and survey data from hundreds of thousands of people to better understand the correction between loneliness and smoking.

Dr. Robyn Wootton, co-lead author of the study said, “This method has never been applied to this question before and so the results are novel, but also tentative. We found evidence to suggest that loneliness leads to increased smoking, with people more likely to start smoking, to smoke more cigarettes, and to be less likely to quit.”

The vicious cycle of loneliness and smoking

One of the most interesting debates about smoking and loneliness is whether or not being lonely leads to smoking. Or, whether smoking leads to increased loneliness.

It’s widely assumed that nicotine, the most addictive substance in tobacco, interferes with dopamine levels in the brain. This could cause people to become more withdrawn and experience less pleasure from daily activities.

Combined with smoking being a form of comfort for most, this starts a vicious cycle of cigarette dependence and comfort from being alone.

What the pandemic has shown us about isolation and smoking

With the pandemic forcing a lot of people to be in isolation, it’s the perfect time for such a study.

YouGov’s Covid-19 tracker, which monitors views and behaviours during the pandemic, suggests more than 2.2 million people across the UK are smoking more than they were before lockdown rules were enforced.

It also suggests that loneliness has increased since the lockdown started, which doesn’t come as a surprise.

Dr. Robyn Wootton added, ‘We were really interested to find that loneliness decreases the likelihood of stopping smoking and we think this is a really important consideration for those trying to stop smoking during the pandemic.’

This means that not only are lonely people more likely to smoke, it’s also harder for them to quit. This is possibly due to the link made earlier between the cycle of dependency on how smoking and loneliness makes someone feel.

Why are loneliness and smoking connected?

The real question is why loneliness and smoking are connected. While the study did produce a lot of data to work with and show a clear correlation, there is still some speculation around the actual reasoning.

Dr. Jorien Treur, senior author of the study said, “Smokers tend to use cigarettes as a way of coping when they feel low. It is likely that feelings of loneliness or depression, which are highly correlated, can diminish people’s capacity to resist grabbing a cigarette.”

Knowing more about the reasons, external or internal, causing people to smoke more or find it difficult to quit is incredibly valuable to aid stop smoking services.

There will almost certainly be more studies into the data produced by this study. The full effects of the lockdown are still yet to be fully realised too, which will provide some more insight into the effects of loneliness on individuals.

How we can help

If you’re trying to quit smoking, here at Ventus Medical we have developed a number of safer NRT products that will help you quit smoking.

Our toxicology and regulatory teams have been working diligently, combining pharmaceutical experience, regulatory expertise, and unique industry insights to develop the safest possible NRT solutions.

If you would like to find out more about Ventus Medical and our products, click here to contact us.