Like lots of prescription drugs, varenicline was motivated by a design template already existing in nature: cytisine, an alkaloid in the seeds of the golden rain tree, native to main and southern Europe. Like varenicline, cytisine is a partial agonist of nicotinic acetylcholine receptors in the brain. Cytisine has been utilized as a smoking-cessation aid in the formerly communist states of Eastern Europe for decades, where it costs less than $30 for a 25-day course.
A brand-new randomized trial in the New England Journal of Medicine is the first to test cytisine versus nicotine replacement therapy. 1,310 cigarette smokers in New Zealand who had called the national quit hotline were randomized to receive either cytisine for 25 days or nicotine replacement treatment for 8 weeks. The treatments were offered complimentary or at really low expense.
Extab likewise moneyed a previous stage III trial, released in 2011, revealing cytisine's superiority over placebo. After a month, 40% of cytisine-takers reported continuous abstinence, compared to 31% of those getting nicotine replacement. The benefits held at 6 months, when 22% of those taking cytisine reported cigarette smoking abstaining compared to 15% of those utilizing nicotine replacement.
Cytisine's numerical benefit over nicotine replacement did not reach analytical significance in this trial. Does cytisine have odd effects on the brain, like the widely known vibrant dreams of Chantix? It may be too quickly to state: about 5% of patients taking cytisine reported "sleep conditions" (due to dreams?) or queasiness; odd dreams and queasiness are amongst the most common reported adverse effects of varenicline.
With this 2nd stage III trial, Extab's goal of bringing cytisine successfully to the masses appears closer to awareness. nicotine patches is reviewing safety information from 8 million Central and Eastern European patients treated with cytisine. There is reasonably little toxicity data available on cytisine, but it is understood to trigger respiratory suppression at high dosages.
The FDA rejected a 2006 demand by supplement makers to market cytisine as a supplement in the U.S., mentioning lack of safety information. Extab hopes additional well-conducted medical trials will overcome those concerns and establish cytisine's place as a safe and reliable smoking cessation aid. Rick Stewart, Extab's CEO told Reuters recently, "Extab anticipates to begin extra Phase 3 medical trials in 2015 with a goal of submitting a New Drug Application with the U.S.
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