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The cash is going to drive it." "It's just discouraging to believe that there's something that could be helping individuals and we're not utilizing it," stated Dr. Nancy Rigotti, director of the Tobacco Treatment Unit at Massachusetts General Medical Facility. A natural product like cytisine can not be patented. That makes its market position more difficult to safeguard.

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Drug companies state the cost of establishing and getting approval for a new drug is $1 billion. This may describe why some companies have actually seen blockbuster earnings with treatments for rare illness, such as Genzyme's drug for Goucher illness, which costs $300,000 a year. "They're fixated on patent protection and brand-new drugs," Stewart stated.

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One is the limited cytisine supply. A competitor would require to plant huge orchards of laburnum trees hundreds of thousands of them and wait 4 years before the drug-containing seeds could be collected. The other thing is that Extab is new to the U.S. market. Nobody has actually ever attempted to get it approved.

market exclusivity as a novel drug under the 1984 Hatch-Waxman Act. That's less than the typical 20-year window for patented medications. However it's something. "It's a really old, unique drug," Stewart states. Still, he needed help getting the drug through the U.S. regulative labyrinth.  cytisine smoking cessation  needed to get lucky. And he did.

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In 2011, the findings were published in the New England Journal of Medication, showing cytisine was 3. 4 times more most likely than placebo to help people quit smoking and remain that way for one year, on par with Chantix. Then a review by University of Sheffield scientists compared cytisine with Chantix and concluded that while more investigation was required, "Cytisine is estimated to be both more clinically effective and cost-efficient than (Chantix)." But the real turning point came in December, when another study was released in the New England Journal of Medication.