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The FDA Gives Breakthrough Therapy Designation For New Drug To Quit Vaping

August 18, 2024
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The FDA Gives Breakthrough Therapy Designation For New Drug To Quit Vaping
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Vaping addiction is on the rise. And now, there’s a publicly traded biotechnology company who wants to be the first to solve it.

What’s happening:

  • Achieve Life Sciences (NASDAQ: ACHV) has been granted Breakthrough Therapy Designation from the FDA for cytisinicline as a potential treatment for helping individuals reduce their addiction and dependence on vaping

The big idea:

  • Cytisinicline is a plant based alkaloid that has a high binding affinity to the nicotinic acetylcholine receptor in the brain which is largely responsible for addiction and dependence on nicotine and tobacco
  • Cytisinicline also is capable of acting as a partial agonist by preventing nicotine from binding to certain receptors in the brain and releasing dopamine
  • Achieve Life Sciences is currently advancing a first of its kind clinical trial focused on their novel drug which uses small doses of cytisinicline as a treatment for individuals who are addicted to vaping

Why it matters:

  • There are currently no approved drugs that are specifically for helping individuals quit vaping, which is becoming increasingly more relevant as the addiction rates for vaping continues to soar globally
  • A Breakthrough Therapy Designation from the FDA is designed to accelerate the review process of new drugs under development in order to bring them closer to final regulatory approvals due to their potential to solve major health issues, which notably was previously given to multiple psychedelic drug development companies

By the numbers:

  • In a recent Phase II trial conducted by Achieve Life Sciences, over 160 different individuals who were addicted to vaping took cytisinicline
  • The individuals who consumed small doses of cytisinicline instead of a placebo were 2.6x more likely to quit vaping by the end of the clinical trial

Going deeper:

  • Cytisinicline as a treatment for quitting vaping addiction has been well tolerated so far in Achieve Life Science’s early clinical trials, showing no adverse side effects and a strong rate of adherence from individuals participating in the trial

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