(RTTNews) – Achieve Life Sciences, Inc. (ACHV), a late-stage specialty pharmaceutical company, on Friday said the U.S. Food and Drug Administration (FDA) has awarded it a Commissioner’s National Priority Voucher (CNPV) for cytisinicline as a treatment for nicotine dependence aimed at e-cigarette or vaping cessation.
This first-of-its-kind designation, granted to only nine therapies in the program’s inaugural year, is intended to provide enhanced FDA engagement and an expedited review process, reducing the agency’s assessment time to one to two months from the standard 10-12 months once all required materials are submitted.
Cytisinicline showed clinical efficacy in the Phase 2 trial, with participants receiving the treatment being 2.6 times more likely to quit using nicotine e-cigarettes or vapes compared with those receiving a placebo.
The FDA has also granted cytisinicline Breakthrough Therapy designation for vaping cessation and has agreed on the Phase 3 trial design. According to the company, the completed Phase 2 study and planned Phase 3 trial would support a supplemental New Drug Application (NDA) for this indication.
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