The opportunity for NVPs as smoking cessation medicines relies on the product delivering satisfying levels of nicotine while meeting pharmaceutical quality standards, and characterisation of its safety, including the potential long-term risks and benefits to the individual.

In state-of-the-science reviews, including that conducted by the US National Academy of Science and Engineering[1] , it is concluded that NVPs have the potential to deliver nicotine with significantly reduced levels of HPHCs compared to combustible cigarettes [2]:

The number of chemicals in cigarette smoke, greater than 7000, exceeds that of NVP aerosol by approximately 2 orders of magnitude[3].Among potentially toxic substances common to both products, cigarette smoke generally contains substantially larger quantities than NVP aerosol[4].

ALLO utilises technological developments and quality manufacturing processes to deliver nicotine with the potential to reduce the risk of tobacco-related disease compared to continuing smoking by implementing:

Systematic processes for flavour ingredient selection, formulation, and toxicological risk assessment.Product development and aerosol analytical evaluation to minimise the presence of harmful constituents in the aerosol compared to tobacco smoke.

Generally, NVPs should aim to reduce potential health risks from harmful constituents of tobacco smoke without introducing new toxicological concerns from the ingredients.

Ingredients

NVP flavouring ingredient safety is characterised by evaluating the acute and long-term health risks of the ingredients and the mixture of ingredients from inhalation exposure.

The products are formulated to minimise long-term risks from inhalation exposure. Also, like any new medicine, post-market surveillance of the clinical population will evaluate the safety during patient use of the product.

Product

ALLO Ultra and SYNC are designed as a closed system products aimed at delivering nicotine to result in similar pharmacokinetics to cigarettes and with power and safety features to:

Ensure satisfying nicotine delivery, while minimising exposure to other excipients in the aerosol; andMinimise aerosol yields of harmful constituents that are found in cigarette smoke.

The ALLO Ultra and SYNC are closed system and liquid composition are designed in tandem to minimise exposures to potentially harmful constituents. Manufacturers should complete a comprehensive evaluation of the aerosol for harmful and potentially harmful compounds.