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Investing.com -- Achieve Life Sciences Inc (NASDAQ:ACHV) stock soared 22.7% in premarket trading Friday after the company announced it received a Commissioner’s National Priority Voucher (CNPV) from the U.S. Food and Drug Administration for its cytisinicline treatment for nicotine e-cigarette or vaping cessation.
The CNPV designation, limited to just nine therapies in the program’s inaugural year, will significantly accelerate the FDA review process for cytisinicline, reducing assessment time from the standard 10-12 months to just one to two months once complete materials are submitted.
Cytisinicline is being developed as a potential first-in-class treatment specifically for e-cigarette or vaping cessation, targeting approximately 17 million adult e-cigarette users in the United States, 60% of whom reportedly want to quit.
"Achieve is redefining the future of nicotine dependence," said Rick Stewart, Chief Executive Officer of Achieve. "This voucher accelerates our path to potentially pioneering the first and only FDA-approved treatment of nicotine dependence for e-cigarette or vaping cessation, which would establish an entirely new category to serve the millions of people who want to quit vaping."
The company’s Phase 2 ORCA-V1 trial showed that participants treated with cytisinicline were 2.6 times more likely to quit using nicotine e-cigarettes compared to placebo. The FDA has also granted cytisinicline Breakthrough Therapy designation for nicotine e-cigarette cessation.
Separately, Achieve recently announced that the FDA accepted its New Drug Application for cytisinicline for smoking cessation, with a target action date of June 20, 2026.
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