Achieve life sciences says co completed meeting with u.s. fda on cytisinicline smoking cessation phase 3 clinical development program

Announces completion of meeting with the u.s. food & drug administration (fda) on cytisinicline smoking cessation phase 3 clinical development program.plans to initiate phase 3 development program in 2020, subject to availability of capital.fda agreed use of newly-developed, single 3.0 mg cytisinicline tablet in phase 3 program was acceptable.fda has agreed with overall phase 3 study designs that will utilize simplified cytisinicline dosing schedule.chronic toxicology study report is expected to be available and submitted to fda in q1 of 2020.fda agreed no further escalation in cytisinicline dosing beyond 30.0 mg dose was necessary for defining maximum tolerated dose.
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