Summary
### **Introduction**
This summary provides an overview of a novel nicotine sublingual tablet developed by IntraTab Labs Inc., presented at the 69th Tobacco Science Research Conference (TSRC) in 2015. The document outlines the product’s unique pharmacokinetic profile, its potential as a harm-reduction tool, and its regulatory and commercialization strategy. Readers will learn about the study design, key findings, and the broader implications for nicotine delivery systems, including its positioning as a safer alternative to traditional smoking and other nicotine replacement therapies (NRTs).
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### **Key Points**
1. **Study Design & Funding**: A pilot human pharmacokinetic (PK) study compared IntraTab’s 2 mg nicotine sublingual tablet to GSK’s 2 mg nicotine lozenge, funded by an NIH STTR grant in collaboration with the Friends Research Institute.
2. **Pharmacokinetic Advantage**: IntraTab mimics cigarette smoking PK, with a **Tmax (time to peak plasma concentration) of ~15 minutes**, compared to 60+ minutes for gum/lozenges, satisfying cravings faster.
3. **Technology**: Uses a **thermodynamic-driven transmucosal delivery system** with only 7 USP-grade ingredients, avoiding the 7,000+ constituents in cigarettes.
4. **Harm Reduction**: Positioned as the **lowest-harm nicotine product**, bridging the gap between combustible tobacco and pharmaceutical NRTs.
5. **Regulatory Pathway**: FDA granted a **505(b)(2) pathway** for 2 mg and 4 mg dosages as NRTs, while the 1 mg version (Nicofi™) is marketed as an unregulated tobacco product.
6. **Commercialization**: The 1 mg product (Nicofi™) was introduced in the U.S. in 2015, with global licensing opportunities for higher doses.
7. **Patent Protection**: Holds worldwide patents (valid until at least 2030 in the U.S.) for its buccal/sublingual drug delivery platform.
8. **Market Positioning**: Designed for **convenience and affordability**, with potential to compete with cigarettes in terms of speed and cost.
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### **Main Message**
The IntraTab nicotine sublingual tablet represents a **scientifically validated, harm-reduced nicotine delivery system** that addresses key limitations of existing NRTs—particularly slow onset of action. By mimicking the rapid PK of cigarette smoking while eliminating combustion-related toxins, it offers a **safer, more effective alternative** for smokers seeking cessation or harm reduction. The product’s regulatory flexibility (both as an NRT and tobacco product) and strong patent protection position it as a **disruptive innovation** in nicotine delivery, with significant commercial and public health potential. For stakeholders in tobacco harm reduction, pharmaceuticals, or nicotine alternatives, IntraTab provides a **compelling solution** that aligns with evolving regulatory and consumer demands.
Citation
McCarty, John. A Novel Nicotine Sublingual Tablet Which Mimics Cigarette Smoking Pharmacokinetics. Presentation, 69th Tobacco Science Research Conference, 21 Sept. 2015.
