04:31 PM EDT, 09/03/2024 (MT Newswires) -- Innocan Pharma ( INNPF ) , on Tuesday said it received a positive response from the U.S. Food and Drug Administration (FDA) for its lead drug product Liposomal Technology-CBD (LPT-CBD).

The FDA has agreed for LPT-CBD's submission under the 505(b)(2) New Drug Application by establishing a scientific bridge to the reference listed drug. The 505(b)(2) abbreviated pathway, as it is often described, typically enables a faster route to patent utilization and commercial approval.

This pathway is a significant milestone for Innocan, as it may pave the way for a streamlined and accelerated FDA approval process for LPT-CBD, while allowing Innocan to advance its patent protected innovation.

In addition, Innocan has reached an alignment with the FDA on both its non-clinical development plan and the clinical study design for LPT-CBD's proposed Investigational New Drug (IND) filing for a Phase I clinical study.

"We are very pleased with the conclusion of our meeting and interactions with the FDA," said Chief Scientific Officer, Professor Chezy Barenholz. "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."

Innocan closed unchange at $0.24 on the Canadian Securities Exchange.