Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
cytisine · 4 trials · 1 indication
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. The percentage of expected cigarettes smoked was computed as Y = (100 x N) / (T x R) where N represents total number of cigarettes smoked each day over the treatment period from Day 1 to Day 25; T represents number of post-randomization days where number of cigarettes smoked is recorded; and R represents the average number of cigarettes smoked daily over the 7-day screening period as baseline. T\*R represents the total number of cigarettes that would have been smoked without intervention over the number of recorded days. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have to have a causal relationship with the treatment. A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event which requires medical intervention to prevent one of the above. Treatment emergent events are those that occurred after the first dose of study drug.
| Arm | Type | Description |
|---|---|---|
| 1.5 mg Cytisine, Commercial Schedule | EXPERIMENTAL | 1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support |
| 3.0 mg Cytisine, Commercial Schedule | EXPERIMENTAL | 3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support |
| Placebo, Commercial Schedule | PLACEBO_COMPARATOR | Placebo tablets using the commercial 25-day titration schedule + behavioral support |
| 1.5 mg Cytisine, TID Schedule | EXPERIMENTAL | 1.5 mg cytisine dose for 25 days using a simplified 3 times daily (TID) schedule + behavioral support |
| 3.0 mg Cytisine, TID Schedule | EXPERIMENTAL | 3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support |
| Placebo, TID Schedule | PLACEBO_COMPARATOR | Placebo tablets for 25 days using a simplified TID schedule + behavioral support |
| Cohort 1: Cytisine 6.0 mg | EXPERIMENTAL | Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 2: Cytisine 9.0 mg | EXPERIMENTAL | Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 3: Cytisine 12.0 mg | EXPERIMENTAL | Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 3: Placebo | PLACEBO_COMPARATOR | Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 4: Cytisine 15.0 mg | EXPERIMENTAL | Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 4: Placebo | PLACEBO_COMPARATOR | Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 5: Cytisine 18.0 mg | EXPERIMENTAL | Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 5: Placebo | PLACEBO_COMPARATOR | Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 6: Cytisine 21.0 mg | EXPERIMENTAL | Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 6: Placebo | PLACEBO_COMPARATOR | Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 7: Cytisine 24.0 mg | EXPERIMENTAL | Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 7: Placebo | PLACEBO_COMPARATOR | Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 8: Cytisine 27.0 mg | EXPERIMENTAL | Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 8: Placebo | PLACEBO_COMPARATOR | Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 9: Cytisine 30.0 mg | EXPERIMENTAL | Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Cohort 9: Placebo | PLACEBO_COMPARATOR | Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. |
| Schedule A: Fed Then Fasted | EXPERIMENTAL | Schedule A (6 participants): * Period 1: cytisine (2 x 1.5 mg tablets) will be administered 30 minutes after the start of a high fat breakfast (fed state) * Period 2: cytisine (2 x 1.5 mg tablets) will be administered after an overnight fast of at least 10 hours (fasting state) |
| Schedule B: Fasted Then Fed | EXPERIMENTAL | Schedule B (6 participants): * Period 1: cytisine (2 x 1.5 mg tablets) will be administered after an overnight fast of at least 10 hours (fasting state) * Period 2: cytisine (2 x 1.5 mg tablets) will be administered 30 minutes after the start of a high fat breakfast (fed state) |
| Name | Type | Description |
|---|---|---|
| Cytisine | DRUG | film coated tablet containing 1.5 mg cytisine in a single tablet |
| Placebo Comparator | DRUG | 1.5 mg cellulose powder to match final weight of the cytisine tablet |
| Behavioral support | BEHAVIORAL | 12 behavioral support sessions by a qualified staff member plus supportive literature and online resources |
| placebo | DRUG | matching placebo oral tablet |
Inclusion Criteria: 1. Male or female subjects, age ≥ 18 years. 2. Current daily cigarette smokers (averaging ≥ 10 cigarettes per day upon completing a 7-day screening diary) and who intend to quit smoking. 3. Expired air carbon monoxide (CO) ≥ 10 parts per million (ppm). 4. Failed at least one pre...
Cytisine is an investigational small molecule being developed for smoking cessation. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in adult smokers to evaluate its effectiveness as a smoking cessation aid.
Cytisine is a small molecule that acts as a nicotinic acetylcholine receptor partial agonist. It binds to the same receptors in the brain that nicotine targets, which may help reduce cravings and withdrawal symptoms associated with smoking cessation.
Cytisine is being developed by Achieve Life Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACHV. The company is conducting clinical trials to evaluate the drug's safety and efficacy for smoking cessation.
Cytisine is currently in Phase 2 clinical development for smoking cessation. It has completed four clinical trials, including Phase 1 and Phase 2 studies, but it remains investigational and has not received FDA approval. The drug is still being evaluated in clinical studies.
Cytisine has completed four clinical trials, including NCT03268343, NCT03509948, NCT03709823, and NCT03848208. These studies evaluated the drug's bioavailability, safety, and efficacy in adult smokers across the United Kingdom, United States, and Portugal.
Cytisine is a distinct investigational compound being developed by Achieve Life Sciences. It is not the same as FDA-approved smoking cessation drugs like varenicline or bupropion. Cytisine is a plant-derived alkaloid that acts as a nicotinic receptor partial agonist, similar in mechanism to varenicline.