Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oromucosal Nicotine Spray (ONS)
Oromucosal Nicotine · 1 trial · 1 indication
cCmax is defined as the maximum baseline corrected plasma nicotine concentration (cCmax).
cAUCt is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point.
cAUC(infinity) is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve extrapolated to infinite.
cAUCt is defined as baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point.
Cav is defined as the average plasma nicotine concentration during the last dosing interval/intervals.
AUCtau is defined as the area under the plasma nicotine concentration-vs time curve during the last dosing interval/intervals.
Cmax is defined as maximum observed plasma nicotine concentration.
| Arm | Type | Description |
|---|---|---|
| Part 1; Treatment Sequence ABDC | EXPERIMENTAL | Participants will receive Treatment A (one spray of oromucosal nicotine spray \[ONS\]) at Visit 1, then Treatment B (2 consecutive sprays of ONS at Visit 2, then Treatment D (1 cigarette \[10 puffs\]) at Visit 3, followed by Treatment C (nicotine gum) at Visit 4. The visits will be separated by a period of at least 7 calendar days. |
| Part 1; Treatment Sequence BCAD | EXPERIMENTAL | Participants will receive Treatment B at Visit 1, then Treatment C at Visit 2, then Treatment A at Visit 3 followed by Treatment D at Visit 4. The visits will be separated by a period of at least 7 calendar days. |
| Part 1; Treatment Sequence CDBA | EXPERIMENTAL | Participants will receive Treatment C at Visit 1, then Treatment D at Visit 2, then Treatment B at Visit 3 followed by Treatment A at Visit 4. The visits will be separated by a period of at least 7 calendar days. The visits will be separated by a period of at least 7 calendar days. |
| Part 1; Treatment Sequence DACB | EXPERIMENTAL | Participants will receive Treatment D at Visit 1, then Treatment A at Visit 2, then Treatment C at Visit 3 followed by Treatment B at Visit 4. The visits will be separated by a period of at least 7 calendar days. |
| Part 2; Treatment Sequence EF | EXPERIMENTAL | Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment E (two consecutive sprays of ONS once every 30 minutes until 11.5 hours) at Visit 5, followed by Treatment F (two consecutive sprays of ONS once every 1 hour until 11 hours) at Visit 6. The visits will be separated by a period of at least 7 calendar days. |
| Part 2; Treatment Sequence FE | EXPERIMENTAL | Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment F at Visit 5 followed by Treatment E at Visit 6. The visits will be separated by a period of at least 7 calendar days. |
| Name | Type | Description |
|---|---|---|
| Oromucosal Nicotine Spray (ONS) | DRUG | Participants will receive oral dose of oromucosal nicotine spray (ONS). |
| Nicotine Gum | DRUG | Participants will chew nicotine gum for 30 minutes. |
| Cigarette | OTHER | Participants will smoke one cigarette as 10 puffs for 3 minutes. |
Inclusion Criteria: * Healthy male or female Japanese participants between the ages of 20 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, blood pressure, pulse rate measurements, 12-lead electrocardiogram (ECG)...
Oromucosal Nicotine is an investigational small molecule nicotine replacement product delivered through the lining of the mouth. It is being developed by Johnson & Johnson (ticker JNJ) as a new oral nicotine replacement option. The specific medical indication has not been disclosed, and the program remains in Phase 1 clinical development.
Oromucosal Nicotine is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 1 study of the product conducted in Japan. No partnership or licensing arrangement for the asset has been disclosed.
Oromucosal Nicotine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program has not been approved by the FDA or any other regulator, and it remains investigational.
Oromucosal Nicotine has been studied in one completed Phase 1 trial, NCT03398876, titled a study to assess nicotine pharmacokinetics, tolerability and safety with a new oral nicotine replacement product in healthy Japanese smokers. The trial enrolled 24 participants in Japan, was randomized and controlled, and included healthy volunteers aged 20 years and older.
Yes. Oromucosal Nicotine Spray, often shortened to ONS, is another name for Oromucosal Nicotine. Both names refer to the same Johnson & Johnson investigational nicotine replacement product delivered through the oral mucosa, so searches for either term point to the same asset.
Oromucosal Nicotine is being developed as a nicotine replacement product, studied in healthy Japanese smokers in its completed Phase 1 trial. The broader therapeutic indication for the asset has not been disclosed. It is an investigational small molecule and is not approved for any use.