Transmucosal Nicotine: 'NicoDrop'

The smoking cessation market is rapidly growing and is estimated to be $1.6 billion in 2010. 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. Jaleva expects to distinguish itself in this market place by proving a transmucosal 'patchless' film that is able to be placed comfortably in the mouth and can deliver a quick, controlled release of nicotine 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.

Jaleva's product NicoDrop 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.

Pre-clinical trials in dogs indicate that NicoDrop has a Tmax of 10 minutes or less, and a Cmax and AUC that is bioequivalent to the Nicorette Lozenge 2mg. NicoDrop's PK profile mirrors that of a cigarette. Phase 1 Pharmacokinetic human trials are being scheduled. Many pharmas have expressed significant interest in NicoDrop since receiving news of NicoDrop's PK data.

The regulatory pathway has been confirmed in writing by the MHRA in Europe and a pre-IND meeting request has been submitted to the FDA for confirmation of the 5045b2 pathway.

Contact Jaleva 877-782-9966 (877-STAYZON) for additional licensing information.