Completion of a Clinical Study

26 September 2016

Christchurch Clinical Studies Trust Announces Completion of a Clinical Study

on Innovative Nicotine-Containing Product

Christchurch, New Zealand – 26 September 2016 – Christchurch Clinical Studies Trust Ltd today announces the completion of a clinical study on an innovative alternative to cigarettes.

The product prototype, designated “P3L” by the technology owner Philip Morris International, mixes nicotine with lactic acid to produce an inhalable nicotine salt aerosol with faster absorption rates than traditional nicotine replacement therapies. The device is the product of technology developed by Professor Jed Rose, co-inventor of the nicotine patch, and his colleagues at Duke University. Previously tested in Christchurch by Dr Chris Wynne and Dr Murray Laugesen, New Zealand’s leading public health specialist, the study validated the belief that P3L can provide smokers with a suitable alternative to smoking.

The study investigated nicotine absorption after a single use of the product by 16 adult smokers in comparison to the Nicorette® inhalator. Approximating the rapid nicotine absorption rates and levels of cigarettes is an important element of providing smokers with a satisfactory alternative to smoking. With P3L, nicotine absorption reached peak levels six times faster than with the inhalator, suggesting easier absorption and a significantly higher potential for acceptance by smokers. The study also assessed a range of subjective effects, as well as safety and tolerability. Compared with use of the inhalator, the study participants found the product a more satisfactory alternative and reported less intention to smoke cigarettes; no relevant side effects were reported.

Conducted in Christchurch, New Zealand, the study was approved by an Independent Ethics Committee, conducted in accordance with the principles of the Declaration of Helsinki, Guidance on Good Clinical Practice and in accordance with the Guideline on the Regulation of Therapeutic Products in New Zealand. The study was registered at www.clinicaltrials.gov (NCT02532374).

Principal study investigator Dr Chris Wynne, Medical Director at St Georges Cancer Care Centre, Christchurch, commented on the results:

“In addition to quitting, which remains the safest way to reduce the harm from smoking, a tobacco harm reduction strategy envisions the development of products with the potential to reduce individual risk compared to smoking. A critical element for acceptance by smokers is nicotine delivery similar to cigarettes as well as the rewarding of subjective effects, and this novel nicotine-containing product has proven to perform better than existing nicotine delivery systems in both areas.”

Given the promising results of this first clinical study, Christchurch Clinical Studies Trust Ltd will conduct further studies to assess in a larger population the potential for smokers to substitute cigarettes with the product.

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