New Nicotine Replacement Therapy: Nicotine Vaccines

The process of quitting tobacco smoking is very difficult for most people. The high level of addiction to nicotine smoking prevents many people from kicking the habit.

New pharmaceutical developments and recent innovation in Nicotine Replacement Therapies (NRTs) provide hope to both consumers and governmental healthcare organizations seeking to curb the rise of chronic diseases derived from tobacco smoking.

Will vaccines replace Nicotine Replacement Therapy (NRT)?

NicVAX developed by NABI Pharmaceuticals is a new nicotine conjugate vaccine that prevents nicotine molecules from reaching the brain. The vaccine builds antibodies that prevent nicotine molecules from crossing the blood barrier and binding into brain cells that produce dopamine, responsible for pleasurable sensations.

The vaccine aims to treat nicotine addiction and improve the relapse rate via re-immunizations. The vaccine is currently in Phase III clinical trials with some preliminary results expected in early autumn 2011. The company is working closely with the Food and Drug Administration (FDA) under a Special Protocol Assessment, and the European Medicines Agency to meet the requirements for a marketing authorisation submission.

GSK Biologicals, a subsidiary of GlaxoSmithKline Plc, signed the option of a worldwide licensing agreement with NABI Biopharmaceuticals in March 2010 to potentially market NicVAX. This strategic move can allow GSK to expand its reach even further into the treatment of nicotine addiction as it is already one of the leading companies in the sales of Nicotine Replacement Therapies (NRTs) in the world.

If successful, NicVAX can potentially cannibalise a portion of Over-the-Counter (OTC) NRTs sales.

The vaccine seems to be more effective in helping people stop their dependence on nicotine. Researchers are developing a vaccine therapy consisting of five to six injections with the ultimate goal to have people develop enough antibodies to quit nicotine dependence in about 14 weeks of treatment.

As opposed to a vaccine, NRTs also need to include further intervention of behavioural therapy to become effective in helping people quit tobacco smoking. In the United Kingdom about 49% of people using “Quit Smoking Services” relapse according to recent figures from the National Health System (NHS) Information Centre. People need good and continuous group support and personal willingness to stick to the NRT process; otherwise it is easy to become prey of cravings for cigarette smoking.

NABI Pharmaceuticals and GSK are not the only ones pursuing a nicotine vaccine. Novartis AG, in partnership with Cytos Biotechnology, is also working on the development of the vaccine NIC-002 that showed unfavourable results in Phase II clinical trials. People participating in the trial did not build enough antibodies to fight dependency more effectively. Celtic Therapeutics Holdings LP (previous Xenova Group Plc) is another biotechnology firm working on a nicotine vaccine, TA-NIC, also at Phase II clinical trials.