Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication CHANTIX is indicated for use as an aid to smoking cessation treatment. CHANTIX is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 ) FDA label
Also known as Varenicline Tartrate, varenicline free base
Varenicline · 18 trials · 3 indications
AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.
Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
Participants considered Responders (4-week CQR \<=10 parts per million \<ppm\>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was \>10 ppm, subject was considered to be Non-Responder at that timepoint.
12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.
| Arm | Type | Description |
|---|---|---|
| Placebo Arm | PLACEBO_COMPARATOR | Randomization 2:1 treatment to placebo |
| Treatment Arm | ACTIVE_COMPARATOR | - |
| placebo | PLACEBO_COMPARATOR | - |
| varenicline | EXPERIMENTAL | - |
| 0.5 mg BID | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Varenicline transdermal delivery system | EXPERIMENTAL | - |
| Varenicline free base solution | EXPERIMENTAL | - |
| Chantix immediate release tablet formulation | ACTIVE_COMPARATOR | - |
| Optional Cohort 4 | OTHER | Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3). |
| Optional Cohort 5 | OTHER | Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3). |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | Randomization 2:1 treatment to placebo |
| varenicline (CP-526,555) | DRUG | One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid |
| Varenicline tartrate | DRUG | - |
| Varenicline | DRUG | 1 mg twice daily by mouth for 12 weeks |
| varenicline free base patch | DRUG | varenicline transdermal delivery system (12.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days |
| placebo patch | DRUG | Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days |
| Varenicline free base solution | DRUG | A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period |
| varenicline free base | DRUG | A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period. |
Inclusion Criteria: * Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month. * Current cigarette ...
Varenicline is a small molecule drug developed by Pfizer, Inc. (ticker PFE). It has been studied in smoking cessation, smoking, and Alzheimer's disease. Varenicline acts as an agonist at the CHRNB2 and CHRNA4 targets. It has been evaluated across 12 completed clinical trials with a total enrollment of 6,680 participants.
Varenicline was studied in a Phase 2 trial for mild-to-moderate Alzheimer's disease, evaluating its effects on cognition, safety, tolerability, and pharmacokinetics. That trial, NCT00744978, enrolled 66 participants in South Korea and has been completed. Varenicline is also studied for smoking cessation and smoking.
Varenicline targets CHRNB2 and CHRNA4, which are nicotinic acetylcholine receptor subunits. It acts as an agonist at these targets. This mechanism underlies its development across smoking cessation and neurological indications such as Alzheimer's disease.
Varenicline is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer has sponsored clinical research on varenicline across smoking cessation, smoking, and Alzheimer's disease indications.
Varenicline has completed 12 clinical trials spanning Phase 1 through Phase 3, with no active trials currently. Its most recent development activity includes a Phase 2 trial in Alzheimer's disease. Varenicline is an investigational agent in this research context and is not described here as approved.
Varenicline trials include NCT00744978, a Phase 2 Alzheimer's disease cognition study in South Korea; NCT00661765, a Phase 1 transdermal delivery study in adult smokers; NCT00644969, a Phase 3 smoking cessation study in patients with schizophrenia or schizoaffective disorder; and NCT00635401, a Phase 2 study in Japanese smokers.
Yes, varenicline tartrate is another name for varenicline. It is also referred to as varenicline (CP-526,555). These names refer to the same small molecule developed by Pfizer, Inc. for smoking cessation, smoking, and Alzheimer's disease research.