Cytisinicline, a plant-based alkaloid used as a smoking cessation ingredient available OTC in some Central and Eastern Europe countries, has shown strong results in two phase 3 studies by a US firm preparing to ask the Food and Drug Administration for approval as a new drug.
US Smoking Cessation Options Could Expand Behind Achieve Life’s Cytisinicline Studies
Achieved Life would seek approval as Rx smoking cessation drug, but ingredient has history of safety and efficacy available OTC in other countries, says lead researcher in study published in Journal of the American Medical Association.
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“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.