Achieve Announces Study Results Demonstrating Similar Bioavailability for New Cytisine Formulation

Achieve Life Sciences announced results of a clinical study evaluating the effect of food on the bioavailability of a new formulation for cytisine.

The study evaluated the bioavailability of a new formulation of 3 mg cytisine under fed and fasted conditions in 12 healthy volunteer smokers. Study results demonstrated bioequivalence when cytisine was administered with or without food. Cytisine was extensively absorbed after oral administration with maximum cytisine concentration levels observed in the blood within less than two hours with or without food. Total excretion levels of cytisine also remained equivalent in both the fed and fasted states, and the 3 mg dose of this new formulation of cytisine was very well tolerated. These results are similar to results evaluating the previous cytisine formulation for bioavailability under fed and fasted conditions in 24 healthy non-smoking volunteers.

"We believe this new cytisine formulation will allow for an extended shelf-life and will be used in the upcoming Phase 2b clinical trial as well as the Phase 3 clinical program," said Rick Stewart, Chairman and CEO of Achieve. "We are pleased with the similar results regarding this new formulation in smokers and that the higher dose of 3 mg cytisine continues to demonstrate a good safety profile with or without food."

Cytisine is an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe for more than 20 years. It is estimated that over 20 million people have used cytisine to help combat nicotine addiction, including over 2,000 patients in investigator-conducted, Phase 3 clinical trials in Europe and New Zealand.

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