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Achieve Life Sciences Announces FDA Grants Breakthrough Therapy Designation to Cytisinicline for the Treatment of E-Cigarette or Vaping Nicotine Dependence
Designation is based on results from the Phase 2 ORCA-V1 trial that showed treatment with cytisinicline more than doubled the odds of quitting e-cigarettes
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"Designation is based on results from the Phase 2 ORCA-V1 trial that showed treatment with cytisinicline more than doubled the odds of quitting e-cigarettes compared with placebo\nSEATTLE and VANCOUVER, British Columbia, July 31, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. “Since there are no FDA-approved medications specifically indicated for nicotine vaping cessation, cytisinicline has the potential to be a first-in-class treatment to address the unique challenges of the over 13 million people in the United States who vape nicotine and are struggling to overcome their addiction,” said Dr. Cindy Jacobs, Achieve’s President and Chief Medical Officer. “Our hope is that with this Breakthrough Therapy Designation and the benefit of increased communication and guidance from the FDA, we can more quickly and efficiently advance cytisinicline as the first approved pharmacotherapy for vaping cessation, not only for adults but potentially in the future for adolescents.” Breakthrough Therapy Designation is designed to expedite the development and review of drugs that are intended to treat serious conditions and when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. It provides product sponsors the ability to receive an FDA cross-disciplinary project management team for interactive communications with senior managers and expert reviewers from the FDA. Achieve plans to hold an End-of-Phase 2 meeting with the FDA’s multidisciplinary team under this Breakthrough Therapy Designation before the end of the year. The FDA considers tobacco dependence to be a serious or life-threatening condition. Long-term e-cigarette use is also becoming recognized as a serious condition based on the potential for serious respiratory, cardiovascular, or other yet unknown risk outcomes. There is also concern regarding adolescent and young adult use given the potential risks on brain development and the strong risk of nicotine addiction as noted...