Additionally, in preparation to initiate a pivotal Phase 3 program in the United States, Achieve recently began enrollment in a multi-dose, pharmacokinetic and pharmacodynamics (PK/PD) clinical study. An assessment of PK parameters and PD effects is planned to be conducted on both the 1.5mg standard and 3.0mg higher-dose of cytisine administered over the currently indicated 25-day scheduled duration of cytisine treatment. The multi-dose PK/PD study is expected to have results within the first-quarter of 2018. |