Rapid Dose Therapeutics Submits QuickStrip(TM) Nicotine Product for Health Canada Approval

Executive Summary

• Rapid Dose Therapeutics Corp. (CSE: DOSE) has submitted a product application to Health Canada for the approval of its QuickStrip™ Nicotine products, marking a significant regulatory milestone toward commercialization.
• The submission covers QuickStrip™ Nicotine in four dosage formats: 1 mg, 2 mg, 3 mg, and 4 mg, representing a proprietary oral nicotine delivery system designed as a safer, smoke-free alternative to combustible cigarettes.
• The company is currently conducting a pharmacokinetic (PK) clinical trial under Good Clinical Practice (GCP) guidelines to compare the absorption and efficacy of QuickStrip™ Nicotine against traditional cigarettes, with results supporting the regulatory submission.

Key Details

• Product Details: QuickStrip™ is a fast-dissolving oral thin film that delivers active ingredients through the oral mucosa. The specific submission is for the NicStrip™ product line in 1 mg, 2 mg, 3 mg, and 4 mg formats.
• Regulatory Action: Submission of a product application to Health Canada for approval.
• Clinical Trials: A pharmacokinetic (PK) study is underway comparing QuickStrip™ Nicotine to traditional combustible cigarettes to evaluate absorption, bioavailability, and efficacy.
• Strategic Partnerships: RDT has collaborated for the past 30 months with a leading global cigarette manufacturer to refine the product. Production is handled by partner Aavishkar.
• Intellectual Property: Two international patent applications under the Patent Cooperation Treaty (PCT) have been filed, covering advancements in nicotine delivery, film formulation, and controlled-release technology.
• Market Context: The Canadian nicotine pouches market was valued at USD 112.2 million in 2024, with projected annual growth of 4.7% through 2030.
• Regulatory History: RDT previously submitted a nicotine product application to Health Canada in 2019, but the process was stalled due to the COVID-19 pandemic.
• Commercial Plans: Upon regulatory approval, RDT plans to launch the product across Canada and expand distribution through commercial partnerships, including potential licensing in other global markets.

Notable Quotes

• "We believe this submission represents a critical advancement in our mission to support harm reduction for smokers... QuickStrip™ offers a convenient, discreet, and non-combustible option." — Mark Upsdell, CEO
• "Our QuickStrip™ delivery system is designed to mimic the nicotine absorption curve of a cigarette without the harmful by products of combustion... It provides rapid onset, consistent dosing, and eliminates second-hand smoke." — Jason Lewis, Senior Vice President