Smoking Cessation Products

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January 2024

Cytisine is a natural ingredient of laburnum seeds and has been used as a smoking cessation aid in Central & Eastern Europe since the 1960s. However, it is unavailable in most countries, including the US. Following the recent regulatory approval in the UK, Consilient Health announced that Cytisine pills, referred as the “aspirin of smoking cessation” by some researchers, will be available in the UK as a prescription-only medicine from January 22, 2024. However, the high price tag (i.e. £115 for a 25-day course of 100 pills) could limit the use of the treatment.

Meanwhile, according to a recent research paper published in the Addiction Journal1, cytisine pills are as effective as varenicline (Champix) and possibly more effective than NRTs (patch & gum) – increasing the chances of success in quitting smoking by more than twofold compared to placebo (~6% quitting success without using any aid).

November 2023

Canadian anti-smoking advocates are calling on the federal government to restrict the sale of ZONNIC2 (recently approved by Health Canada) and seeking a moratorium on approval for any other nicotine pouches, unless they are made available only by prescription. The groups claim that

– while ZONNIC is marketed as a “nicotine replacement therapy” for adults, it is available for sale at convenience stores and gas stations with no legal restrictions on who can buy it

– ZONNIC’s social-media posts feature images of young people and highlight the product’s (youth appealing) flavors such as berry frost and tropic breeze.

In response, Imperial Tobacco Canada (part of BAT group) issued a statement3 noting that

– Despite the criticism from health groups, they believe that ZONNIC will help adult Canadians smokers quit and they support support regulations that limit the sale NRT category to adults 18 years old and over

– ZONNIC is licensed, regulated and advertised in the same way as any other smoking cessation product on the market

– There should be no reason why they should be singled out for adding another innovative choice to the market to help adult smokers quit.

Is this the best strategy for BAT to follow? In Canada, nicotine pouches (<4mg nicotine) are classified as “Natural and Non-prescription Health Product” and are marketed upon receiving a market authorization from Health Canada. BAT is using this rightful commercialization pathway to place ZONNIC on the market. Meanwhile, the regulatory status of nicotine pouches are unclear in many countries around the world and, in many cases, they are de-facto classified as consumer product – only subject to general product safety rules. Many countries (especially, the EU and EU states) are going through the process of deciding on the regulatory status of this emerging nicotine product category. Shifting the attention to Canada and putting the “Pharmaceutical/NRT” pathway as a viable/effective option to reach the intended audience (“smokers who want to stop smoking”) may not be in the best interest of tobacco companies at this stage. It won’t be easy to sell the idea that ZONNIC and VELO are different products based on the approval process and product placement/claims. If EU and other developed markets classify nicotine pouches as NRTs (limiting the distribution channels and access to the product, except for a handful of markets), we will slash the category’s global market potential for the tobacco companies by half (- the rest will mostly be the US, Scandinavia and UK).

Food for thought: maybe BAT is better off by being singled out from the Canadian NRT market until the regulatory status of nicotine pouches are clarified in key jurisdictions.

October 2023

Imperial Tobacco Canada (ITCAN), part of BAT group, will launch ZONNIC nicotine pouch as a smoking cessation product4 following the “license to sell” granted to BAT’s subsidiary, Nicoventures, by Health Canada. ZONNIC is the first nicotine pouch to receive Health Canada’s authorization. The licence application made to Health Canada included a pharmacokinetics study that assessed the bio-availability of nicotine in ZONNIC in comparison to other commercially available NRTs.

Niconovum, which sells own NRT products under the ZONNIC brand name in Nordics and also manufactures private-label NRT products, was acquired by Reynolds American (RAI) in 2009. Following the acquisition of RAI by BAT in 2017, Niconovum was brought under the umbrella of Nicoventures – a standalone company established by BAT in 2011 to exclusively focus on the development and commercialization of regulatory-approved, innovative nicotine products.

September 2023

After the disappearance of Champix (Pfizer) and Zyban (GSK) from the market, NRT is currently the only pharmacological treatment available in the UK. But, the trial data on cytisine puts a new treatment on the horizon5. Cytisine is a medicine that has been used as a smoking cessation aid in Central & Eastern Europe since the 1960s and could become the “aspirin of smoking cessation” according to researchers.

July 2023

Haleon is exploring the sale of Nicotinell (nicotine gum, patches and lozenges) as it seeks to offload non-core businesses6. Nicotinell attracts interest from both investment firms and consumer companies and is claimed to be worth as much as $800Mn.

Background:

UK National Health Service (NHS) lists 4 “Stop Smoking Treatments” on its website7.

(1) Nicotine replacement therapy (NRT): Reduces the withdrawal effects by providing a low level of nicotine. NRTs include nicotine patches, gums, inhalators, tablets/strips/lozenges as well as nasal & mouth sprays. Also available on prescription.

(2) Varenicline (Champix): Both reduces nicotine craving and blocks the rewarding/reinforcing effects of nicotine. Prescription only.

(3) Bupropion (Zyban): (Thought to) Affect the parts of the brain involved in addictive behavior. Prescription only.

(4) E-cigarettes: Not a pharmacological treatment. Nevertheless, NHS recommends e-cigarettes as a stop smoking aid – in this regard, NHS is pretty unique providing a positive recognition to the product. For instance, the US FDA recognizes only the first three products as the “Quit Smoking Treatments”8.

References:

  1. https://onlinelibrary.wiley.com/doi/epdf/10.1111/add.16399 ↩︎
  2. Health Canada-approved Zonnic flavoured nicotine pouches target teens, say health experts – The Globe and Mail ↩︎
  3. Imperial_Tobacco_Canada_stands_by_ZONNIC_as_a_tobacco_harm_reduction_tool.pdf (imperialtobaccocanada.com) ↩︎
  4. Imperial Tobacco Canada: Zonnic Launch ↩︎
  5. https://pharmaceutical-journal.com/article/feature/filling-the-gap-in-smoking-cessation-therapies-a-race-to-a-smoke-free-2030 ↩︎
  6. https://www.bloomberg.com/news/articles/2023-07-03/advil-owner-haleon-said-to-mull-sale-of-nicotine-gum-business ↩︎
  7. https://www.nhs.uk/conditions/stop-smoking-treatments ↩︎
  8. https://www.fda.gov/consumers/consumer-updates/want-quit-smoking-fda-approved-and-fda-cleared-cessation-products-can-help ↩︎

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