Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NicoDerm CQ patch · 1 trial · 1 indication
Cmax was the highest observed plasma nicotine concentration of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was reported. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed pharmacokinetic (PK) variables, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
Area under the plasma concentration versus time curve from time zero to time t, where t was the time of the last measurable plasma concentration of nicotine, estimated, computed using the linear trapezoidal rule. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed PK variable, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
Area under the plasma concentration versus time curve calculated from time zero to infinity. AUC0-inf = AUC0-t + C(t)/λz. C(t)- Concentration at the last measurable sampling time point and λz- terminal elimination rate constant. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed PK variable, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
| Arm | Type | Description |
|---|---|---|
| Test Product | EXPERIMENTAL | Participants will receive a single NicoDerm CQ patch (GSK Dungarvan) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours. |
| Reference Product | ACTIVE_COMPARATOR | Participants will receive a single NicoDerm CQ patch (Alza) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours. |
| Name | Type | Description |
|---|---|---|
| NicoDerm CQ patch (GSK Dungarvan) | DRUG | A single patch of a NicoDerm CQ (GSK Dungarvan) 21 mg per system of 22 centimeter square (cm\^2) surface area will be placed topically. |
| NicoDerm CQ (Alza) | DRUG | A single patch of a NicoDerm CQ (Alza) 21 mg/system of 22 cm\^2 surface area will be placed topically. |
Inclusion Criteria: * Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Participant is willing and able to comply with scheduled visits, treatment plan, ...
NicoDerm CQ patch is a small molecule drug used for Tobacco Use Disorder, a condition involving nicotine dependence. It is a transdermal patch designed to deliver nicotine to help manage withdrawal symptoms. The drug is being developed by Haleon plc, a company listed on the stock exchange under the ticker HLN.
NicoDerm CQ patch targets nicotine receptors in the brain by delivering nicotine through the skin. This mechanism helps reduce cravings and withdrawal symptoms associated with Tobacco Use Disorder. The patch provides a controlled release of nicotine, which is the active ingredient, to support smoking cessation efforts.
NicoDerm CQ patch is developed by Haleon plc, a global consumer healthcare company. Haleon is publicly traded on the stock exchange under the ticker symbol HLN. The company is responsible for the development and commercialization of the product, which is intended for the treatment of Tobacco Use Disorder.
NicoDerm CQ patch is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its bioequivalence in healthy adult smokers, and it is not yet available for general use in the treatment of Tobacco Use Disorder.
NicoDerm CQ patch has one completed clinical trial, identified as NCT05024747. This Phase 1 study evaluated the bioequivalence of a 21 milligram nicotine transdermal patch compared to a currently marketed version in healthy adult smokers. The trial enrolled 22 participants in the United States and was active-controlled, meaning it compared the drug to an existing treatment.
NicoDerm CQ patch is a branded nicotine transdermal patch. The clinical trial NCT05024747 compared a 21 milligram version of the patch to a currently marketed version of the same product. The study was designed to assess bioequivalence, which means it aimed to determine if the two versions deliver the same amount of nicotine to the body.