PFE - Achieve Life Sciences: 1st Half 2025 NDA Filing On Track With FDA Agreement

2024-07-01 13:46:15 ET

Summary

• Achieve Life Sciences, Inc. initiated an open-label ORCA-OL trial using cytisinicline for smoking cessation; the Efficacy of the drug already established in several prior studies.
• Alignment with FDA that successful completion of ORCA-OL trial is necessary for NDA filing of cytisinicline in the 1st half of 2025.
• The global smoking cessation product market is estimated to reach $69.8 billion by the end of 2034.
• Potential label expansion opportunity exists of using cytisinicline for e-cigarettes or vaping cessation patients; End-of-phase 2 meeting expected in 2024.

Achieve Life Sciences, Inc. ( ACHV ) has done well to advance its main clinical program, which would be the use of its drug cytisinicline for smoking cessation. The company has had an extensive program, where it has run several trials proving the efficacy of this drug for these patients. One major item to note is that the FDA is worried about long-term safety use of such a drug. Having said that, there was an agreement reached with the FDA that the open-label ORCA-OL clinical trial would be enough to provide evidence of the safety of this drug for smoking cessation....

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