The smoking cessation market is rapidly growing and was estimated to be $1.6 billion in 2010, and 2.5B in 2014. The growth of the smoking cessation therapies market is driven by the recent surge in public awareness of the dangers of smoking, legislation banning smoking in many public areas, and the development of pharmacotherapies for treatment of nicotine addiction.
The smoking cessation market is dominated by nicotine replacement in multiple delivery forms: transdermal patch, gum, nasal spray, and the newest formulation, inhaler. ART expects to distinguish itself in this market place by providing a transmucosal ‘pathless’ very small film that is able to be placed comfortably in the mouth and can deliver a quick, controlled release of nicotine. And it can do so without the issues associated with the currently available modes of delivery. Smokers who are trying to cut down or quit develop powerful nicotine cravings that lead them to smoke again. These cravings are not satisfied by current technology, such as Nicoderm patches or Nicorette gum. Many smokers do not want the adverse side affects associated with current products, inhalers or sprays.
ART product NicoSwab is formulated to safely satisfy smokers’ cravings by maximizing nicotine delivery to the bloodstream within 10 minutes, promoting smoking reduction and quitting over a 12 week period. NicoSwab’s PK profile mirrors that of a cigarette.
ART successfully completed pre-clinical and phase 1 clinical tests on this stable, transmucosal Nicotine Replacement Therapy (NRT) product (NicoSwab) that outperforms Nicorette Gum®, Quickmist® and Nasal Nicorette®. Results indicate that NicoSwab has a Tmax of 10 minutes or less, and a Cmax and AUC that is bioequivalent to the Nicorette Lozenge 2mg.
The product is ready for market launch in the $2.5B smoking alternative marketplace. Trial batches were manufactured, and test marketing resulted in overnight success with the trial batch being sold-out and retailed in over 100 stores.
When ART or a licensing company chooses to, Phase 1 Pharmacokinetic human trials and protocols were determined. The regulatory pathway has been confirmed in writing by the MHRA in Europe and a pre-IND meeting request was submitted to the FDA for confirmation of the 505b2 pathway.
Contact ART for additional licensing information.