Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nicotine · 3 trials · 1 indication
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)
Average Nicotine Plasma Concentration (Cav) within the last dosing interval
Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)
The average concentration of nicotine in the blood. \* The dosing interval (τ) in this study will be one (1) hour. Consequently, Cav will have the same value as AUCτ (but with a different unit), since Cav is calculated as AUCτ divided by τ. Therefore Cav will not be displayed in results, only AUCτ.
AUCτ is the area under the plasma concentration-vs.-time curve during the last dosing interval and is a measure of how much of the drug reaches the person's bloodstream. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve is calculated as hour \* nanograms (ng) per milliliter (mL).
| Arm | Type | Description |
|---|---|---|
| Nicotine | EXPERIMENTAL | Nicotine Spray |
| Placebo | PLACEBO_COMPARATOR | Placebo to match Nicotine spray |
| NRT 60 | EXPERIMENTAL | A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits |
| NFG 60 | ACTIVE_COMPARATOR | A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits |
| NRT 90 | EXPERIMENTAL | A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits |
| NFG 90 | ACTIVE_COMPARATOR | A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits |
| NIQ 60 | ACTIVE_COMPARATOR | A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits |
| N1/3-I5 | EXPERIMENTAL | 5 mg Inhalation during 10 minutes every hour for 11 hours with a puff frequency of four puffs per minute, with a 36-hour washout between visits |
| NX-I10 | ACTIVE_COMPARATOR | 10 mg Inhalation during 10 minutes every hour for 11 hours with a puff frequency of four puffs per minute, with a 36-hour washout between visits. |
| Name | Type | Description |
|---|---|---|
| Nicotine Spray | DRUG | Nicotine Spray |
| Placebo | DRUG | Placebo to match nicotine spray |
| Nicotine | DRUG | 6 mg experimental Nicotine Replacement Therapy (NRT) |
Inclusion Criteria: Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking Exclusion Criteria: History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained. Use of other forms of to...
Nicotine is used for tobacco dependence and smoking cessation. It is a small molecule being developed by Johnson & Johnson (JNJ) as a nicotine replacement therapy. The drug is currently in Phase 3 clinical development for these indications.
Johnson & Johnson (ticker: JNJ) is developing Nicotine for tobacco dependence and smoking cessation. The drug is a small molecule currently in Phase 3 clinical trials.
Nicotine is in Phase 3 clinical development for tobacco dependence and smoking cessation. It is an investigational drug and not yet approved by the FDA. All completed trials include Phase 1 and Phase 3 studies.
Nicotine has completed five clinical trials, including NCT00966901, NCT01321931, NCT01478230, and NCT02355665. The Phase 3 trial NCT02355665 enrolled 1,198 participants in the United States to evaluate efficacy and safety of a novel nicotine replacement therapy.
Nicotine is a nicotine replacement therapy product being developed by Johnson & Johnson. It is intended to help people quit smoking by replacing nicotine from cigarettes. The drug is in Phase 3 trials for tobacco dependence.