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Achieve Announces FDA Acceptance of the Investigational New Drug Application for Cytisine as a Smoking Cessation Treatment

By August 14, 2017No Comments

Achieve Life Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for cytisine, an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe for more than 15 years. The company is now authorized to proceed with clinical development of cytisine in the U.S.

Cytisine is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor.  It is estimated that over 20 million people have used cytisine to help combat nicotine addiction, including approximately 2,100 patients in Phase 3 clinical trials conducted in Europe and New Zealand. Achieve expects to commence a Phase 3 trial of cytisine in the United States in the first-half of 2018.

“FDA acceptance of the cytisine IND represents a significant milestone for Achieve, providing further validation of our objective to obtain FDA approval for cytisine and bring this important therapy to people battling nicotine and tobacco addiction,” said Rick Stewart, Chairman and CEO of Achieve. “We are extremely grateful for the support and commitment we have received from the National Institutes of Health (NIH), which has sponsored a number of non-clinical studies to enable our IND submission.”

According to the U.S. Surgeon General’s 2014 report¹ “The Health Consequences of Smoking – 50 years of Progress”, there are more than 16 million Americans living with diseases caused by smoking and it is responsible for more than 480,000 deaths per year. The report states that productivity losses from premature death exceed $150 billion per year and the annual costs of direct medical care of adults attributable to smoking are estimated to be over $130 billion.

“Given the burden of smoking-related illnesses, cytisine could be a potential drug of public health importance. NCCIH efforts in collaboration with the NIH Blueprint Neurotherapeutics Network, and the National Cancer Institute Developmental Therapeutics Program, have contributed to our understanding of cytisine’s safety profile, which is needed for clinical development.  With further clinical testing, if cytisine is approved by the FDA, another smoking cessation option would be available to help reduce the number of lives lost due to tobacco smoking and nicotine addiction,” said David Shurtleff, Ph.D., NCCIH deputy director.

Two prior, large-scale Phase 3 clinical studies of cytisine, with favorable outcomes, have been successfully completed in over 2,000 patients. The TASC trial was a 740 patient, double-blind, placebo controlled trial conceived by Professor Robert West at University College London and funded by the U.K. National Prevention Research Initiative. The CASCAID trial was a 1,310 patient, single-blind, non-inferiority trial comparing cytisine to nicotine replacement therapy (NRT). The CASCAID trial was conceived by Dr. Natalie Walker, National Institute for Health Innovation, University of Auckland and funded by the Health Research Council of New Zealand. Both trials were published in the New England Journal of Medicine.