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.