Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nicotine Patch · 5 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| LHN1548 | EXPERIMENTAL | Two single doses of an experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period. |
| 2019706 | ACTIVE_COMPARATOR | Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period. |
| 2020005 | ACTIVE_COMPARATOR | Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period. |
| Three Treatment Sites UV Exposed | EXPERIMENTAL | All three test sites exposed to UV radiation after patch removal. Induction: 10 J/cm2 UVA and 0.5 MED UVB, one treatment after first patch removal; and 3 MED UVB at the 5 following treatments. Challenge: 4 J/cm2 UVA and 0.5MED UVB, one treatment.( MED: Minimal Erythema Dose determined during screening) |
| Three Interventions on Lower Back | EXPERIMENTAL | Three treatments were applied on the lower back, according to treatment sequence, daily for 21 days |
| Both Treatments Applied on Lower Back | EXPERIMENTAL | Treatments were applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h. |
| Three Treatments Applied to Lower Back | EXPERIMENTAL | Treatments were applied on the lower back, according to treatment sequence, daily for 21 days. |
| Name | Type | Description |
|---|---|---|
| Nicotine | DRUG | Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period |
| Nicotine Patch | DRUG | 25 mg nicotine patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h. |
| Placebo Patch | DRUG | As a positive control, a placebo patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h. |
| No Patch Control | DRUG | As a negative control, a marked site on the lower back or buttock was assigned as test area, but no patch was applied. |
| UVA and UVB irradiation | RADIATION | All three test sites exposed to UV radiation after patch removal. Induction: 10 J/cm2 UVA and 0.5 MED UVB, one treatment after first patch removal; and 3 MED UVB at the 5 following treatments. Challenge: 4 J/cm2 UVA and 0.5MED UVB, one treatment.( MED: Minimal Erythema Dose determined during screening) |
| Nicotine Patch Comparator | DRUG | 15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days |
| SLS Comparator Patch | DRUG | 0.1% (w/v) SLS patch applied on the lower back, according to treatment sequence, daily for 21 days. |
Inclusion Criteria: * Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion, and smoking within 30 minutes of waking up. * Female participants of child-bearing potential are required to use a medically acceptable means of birth control. * A personally si...
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.