Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nicotine gum (C)
Nicotine gum · 2 trials · 1 indication
The maximum reduction in Visual Analog Scale (VAS) score for the question "Urges to smoke" (Tobacco/Nicotine Withdrawal Questionnaire) between pre-use and post-use (i.e., VASpre-use1 - VASpost-use1) during the first product use in Part B.
The largest VAS score recorded for the response to the question "Is the product "Pleasant" right now?" (Direct Effects of Product Questionnaire) during the first product use in Part B.
| Arm | Type | Description |
|---|---|---|
| VLN Menthol Cigarettes (A) | EXPERIMENTAL | Subjects will smoke VLN menthol cigarettes |
| Usual Brand Menthol Cigarettes (B) | EXPERIMENTAL | Subjects will smoke their usual brand menthol cigarettes |
| Nicotine Gum (C) | EXPERIMENTAL | Subjects will chew nicotine gum |
| VLN Cigarettes (A) | EXPERIMENTAL | Subjects will smoke VLN cigarettes |
| Usual Brand Cigarettes (B) | EXPERIMENTAL | Subjects will smoke their usual brand cigarettes |
| Name | Type | Description |
|---|---|---|
| VLN menthol cigarettes (A) | OTHER | 0.4mg nicotine / g tobacco king size filter menthol cigarette |
| Usual Brand Menthol Cigarettes (B) | OTHER | Usual brand king size menthol cigarettes |
| Nicotine gum (C) | DRUG | 4 mg nicotine gum |
| VLN cigarettes (A) | OTHER | 0.4mg nicotine / g tobacco king size filter cigarette |
| Usual Brand Cigarettes (B) | OTHER | Usual brand king size non-menthol cigarettes |
Inclusion Criteria: Subjects will be required to meet each one of the following inclusion criteria in order to be eligible for participation in the study: 1. Must provide written informed consent prior to the initiation of any protocol-specific procedures. 2. Male and female adults, between 22 to ...
Nicotine gum is being studied for tobacco use, with 22nd Century Group developing it as part of its very low nicotine product portfolio. The two completed Phase 1 trials evaluated abuse liability in adult smokers, including a mentholated version, rather than testing the gum as a smoking cessation aid.
22nd Century Group, Inc., which trades under the ticker XXII, is the developer of this nicotine gum asset. The company is known for plant biotechnology and reduced-nicotine tobacco products, and this program sits within its tobacco use research pipeline.
Nicotine gum is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA for tobacco use or any other indication.
Two completed Phase 1 trials are registered: NCT03559751, which evaluated abuse liability of very low nicotine cigarettes in 66 participants, and NCT03559725, which evaluated abuse liability of very low nicotine mentholated cigarettes in 55 participants. Both were conducted in the United States.
Yes, nicotine gum (C) is an alternative name for nicotine gum. Both refer to the same 22nd Century Group product candidate being studied in tobacco use, so searches using either name point to the same Phase 1 program.