Ditch Labs Inc. Advances Regulatory Pathway Following a Successful Scientific Advice Meeting with UK MHRA

Montreal, QC, February 24, 2025 – Ditch Labs Inc., a pioneering life sciences company dedicated to transforming smoking and vaping cessation with its DitchPen®, recently held a highly constructive discussion with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. This pivotal Scientific Advice Meeting (SAM) marks a major milestone in Ditch Labs’ regulatory journey as it moves toward submitting a Marketing Authorization Application (MAA) in the UK in 2026.

During the meeting, the MHRA provided valuable regulatory guidance on several key areas:

  • Drug product, device, and app compliance – Confirmed that the anticipated regulatory standards align with Ditch Labs’ expectations. All manufacturing and testing partners are already in place to meet these requirements.

  • Non-clinical study expectations – Validated the adequacy of Ditch Labs’ proposed toxicity and safety assessment plan.

  • Clinical development requirements – Outlined the pivotal comparative bioavailability trial necessary to support future marketing authorization. Ditch Labs has already established its regulatory and clinical documentation, along with research collaborations for this study.

  • Regulatory classification and prescription status – Clarified that the DitchPen® will be classified as a medicinal product and a Class IIa medical device, available without a prescription for individuals aged 18 and older.

Receiving regulatory feedback at this stage is a crucial step in our journey to making the DitchPen® available as a promising treatment, ensuring it meets the highest standards of safety and efficacy,” said Christelle Luce, Ph.D., Co-founder & Chief Scientific Officer of Ditch Labs. “We deeply appreciate the MHRA’s progressive and visionary approach, which strongly supports harm reduction and innovation in nicotine cessation,” added Laurent Laferrière, Co-Founder & Chief Executive Officer of Ditch Labs.

For nearly five years, Ditch Labs has been developing a groundbreaking innovation in nicotine replacement therapy (NRT). Using a dual-tank precise dosing technology paired with a companion mobile app, the treatment offers individuals looking to reduce or quit smoking a holistic, personalized approach with automated gradual weaning.

This breakthrough marks a major advancement, as the NRT field has seen little innovation in over 20 years. Despite decades of public health efforts, more than 1.2 billion people worldwide still smoke, and tobacco-related diseases claim 8 million lives each year.

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