Achieve Life Sciences, Inc. (NASDAQ: ACHV) shares sprang to life Wednesday, after the company reported advancement of cytisine development program following a meeting with the Food and Drug Administration.
The Seattle-based Achieve, a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisine for smoking cessation, today announced an update on the cytisine development program following a meeting conducted with the FDA.
The meeting with the FDA on the non-clinical and clinical development plans has further defined Achieve's Phase 3 clinical program and expected future New Drug Application (NDA) submission.
Based on the FDA's recommendations to further characterize cytisine dosing prior to NDA submission, Achieve plans to conduct a Phase 2boptimization trial in approximately 250 smokers in the U.S., with various cytisine dosing schedules to evaluate overall treatment efficacy, safety, and compliance profiles for cytisine.
"The successful outcome of our discussions with the FDA has provided us with clarity and direction to better inform our Phase 3 clinical development program and our efforts toward expanding cytisine availability," said CEO Rick Stewart.
"Smoking is responsible for the deaths of nearly a half a million Americans every year and new treatment options are desperately needed to help those battling nicotine addiction."
Indeed, tobacco use is currently the leading cause of preventable death and is responsible for nearly six million deaths annually worldwide. It is estimated that 28.6% of all cancer deaths in the U.S. are attributable to cigarette smoking.
Shares rocketed $1.53, or 42.2%, to $5.15
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