FDA Backs Innocan Pharma’s Liposomal CBD After Key Meeting

Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) ("Innocan" or the "Company"), a trailblazer in the pharmaceutical and biotechnology sectors, is excited to share that it has received favorable feedback from the U.S. Food and Drug Administration (FDA) after a successful pre-Investigational New Drug (pre-IND) Type B meeting held in July, focusing on its flagship product, Liposomal Technology-CBD (LPT-CBD).

The FDA has endorsed the submission of LPT-CBD under the 505(b)(2) New Drug Application (NDA) pathway, which establishes a scientific link to an existing reference drug. This abbreviated pathway is often recognized for its potential to expedite patent usage and commercial approval. For Innocan, this is a crucial achievement, as it could lead to a more efficient and accelerated FDA approval process for LPT-CBD, while furthering the company’s patent-protected innovation.

Moreover, Innocan has successfully aligned with the FDA on its non-clinical development strategy and the clinical study design, setting the stage for the proposed Investigational New Drug (IND) submission for a Phase I clinical trial of LPT-CBD.

Professor Chezy Barenholz, Innocan's Chief Scientific Officer said in a statement, "We are very pleased with the conclusion of our meeting and interactions with the FDA. We now have a clear and straight forward pathway toward generating the data needed for the initiation of our clinical study with LPT-CBD to treat chronic pain."

Dr. Eyal Kalo, Research and Development Director of Innocan, added "Innocan is fully committed to bringing new opportunities for chronic pain management," 

Chronic pain is a serious condition that affects around 20% of the population (1of 5 US Adults) (*) with significant unmet needs. The positive FDA feedback is a crucial milestone for us, enabling the advance of LPT-CBD to market and bring much-needed relief to millions suffering from chronic pain."

Dr. Joseph Pergolizzi, COO of NEMA Research Inc, a recognized expert in chronic pain and an advisory board member at Innocan, underscored the point, "Given the current standard of care for chronic pain, we believe clinicians' ability to address existing gaps will be significantly enhanced by LPT-CBD.”

Iris Bincovich, CEO of Innocan, emphasized the sustained release of CBD observed in nonclinical studies of LPT-CBD, and further mentioned, "Our work is a crucial element in the fight against chronic pain, bringing a novel technological approach to the forefront.”