Innocan Pharma Corporation has announced a key achievement with the submission of its letter of application for a Pre-IND meeting to the United States Food and Drug Administration (FDA). This key step initiates the FDA approval process for Innocan's Liposome-Cannabidiol (LPT-CBD) injectable treatment designed to address chronic pain.
The global pain therapeutics market, expected to surpass USD 100 billion by 2032, highlights the pressing need for effective alternatives to opioid-based treatments. With opioids contributing to a staggering three-quarters of drug overdose deaths in the United States, according to the United States Center for Disease Control and Prevention, the demand for safer and more sustainable pain management solutions has never been more urgent.
Innocan's LPT-CBD therapy has demonstrated consistent efficacy in multiple pre-clinical trials, showcasing its potential to revolutionize pain management through prolonged and controlled release of CBD in animals with chronic pain conditions.
The submission of Innocan's Pre-IND Meeting Request Letter to the FDA represents a crucial milestone in the journey toward approval for human use. The upcoming Pre-IND meeting will serve as an opportunity to seek guidance from the FDA on the preclinical and clinical development plan, paving the way for the initiation of an Investigational New Drug (IND) program in the United States.
Iris Bincovich, CEO of Innocan, expressed enthusiasm for the company's progress, stating, "We are extremely excited to embark on this next stage in the development of LPT-CBD injectables. This is a major milestone for Innocan Pharma, reflecting our dedication to advancing innovative therapies for chronic pain management." Bincovich emphasized the company's significant investment in research and development, highlighting the wealth of preclinical data that will underpin its engagement with the FDA.
Dr. Joseph Pergolizzi, a key member of Innocan's FDA Advisory Board, underscored the importance of the data collected during the company's animal LPT therapy testing program. "We have meticulously prepared this data for submission to the FDA and eagerly anticipate working under FDA guidance to expedite the review process," Dr. Pergolizzi commented. He emphasized the potential of Innocan's unique treatment method to serve as a valuable non-opioid addition to the medical toolkit for chronic pain management, once FDA-approved.
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