Champix – Pfizer’s Development to Fight Smoking


December 21, 2005 - Pfizer Inc. –

A new medication from Pfizer Inc. to treat smoking addiction has recently received the priority review status from the American Food and Drug Administration (FDA). According to the company’s official press-release, Pfizer intends to market the new drug, known as varenicline, under the brand name Champix, provided that it will pass all the necessary tests and revisions by FDA.

Priority review status means that FDA will review all the data on the said medication in the nearest 6 months in order to make the decision on its approval for use on the territory of the USA. Taking into account actual threats of smoking addiction and rather limited range of treatment options to fight the disease, FDA is interested in the development of specially designed medications that would be able to demonstrate significant effectiveness and safety in helping people quit smoking.

Pfizer Inc. started the development of its new drug in 1993 with a completely new approach to the smoking problem solution, based on the understanding of smoking addiction mechanism. There is a nicotine receptor in human brains, which is responsible for smoking addiction and for the nicotine cravings along with the withdrawal symptoms.

New investigational drug, varenicline, is designed to influence the nicotine receptor in a certain manner. It stimulates the receptor, like nicotine does, thus satisfying the cravings, but on the other hand, the stimulation is weaker, so it does not cause the addiction and does not contribute to the new cravings.

Varenicline’s mode of action was once compared to a 50-watt light bulb in the receptor, while the nicotine from a cigarette works like a 100-watt bulb in the brains.

For the time being, there is only one non-nicotine medication, used to treat smoking addiction. It is Zyban. But taking into account, that it was initially developed as an antidepressant, Champix may become the first medication, designed specifically to treat smoking.

As for the effectiveness and safety of a new medication, the full information is still unavailable due to a fact that varenicline is still in the trial phase. In the meantime, there is some data, received during seven-week study, which shows that 48 % of patients, treated with varenicline, were able to quit smoking. For comparison: treatment with Zyban ensured the positive results in 33% of participants.

Pfizer informs in its press-release that in all the trials, varenicline was well tolerated and caused such side effects, as nausea, headache, trouble sleeping and abnormal dreams.

Finally, it is interesting to note, that the development of varenicline is based on a 40-years old research by Soviet scientists. They discovered a cytisine, a chemical in many plants, which seemed to help people quit smoking by blocking the nicotine receptor in the brains.

In case of FDA approval of Champix for use in treating smoking, this medication has all the chances to repeat the world triumph of Viagra, a Pfizer’s creation to treat male erectile dysfunction.

Nick


External resources
http://www.pfizer.com/pfizer/are/investors_releases/2005pr/mn_2005_1221.jsp


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