11:15 ET BRC Therapeutics Announces Peer-Reviewed Publication on Navigating Drug Development Pathways for Botanical Cannabinoid Medicines

Botanically derived cannabinoid therapeutics present unique regulatory, scientific, and commercial opportunities alongside development challenges. BRC's publication may serve as a roadmap for the commercialization of safe, consistent, and evidence-based therapeutic options. , /PRNewswire/ -- BRC Therapeutics (BRC), a pharmaceutical company developing proprietary therapeutics for neurological and inflammatory diseases, today announced the publication of a peer-reviewed commentary in the journal Clinical Therapeutics describing challenges inherent in developing botanically derived cannabinoid therapeutics and how they may be overcome through concerted efforts by drug developers, regulators, and healthcare providers. Cannabinoid medicines have significant potential to treat underserved conditions and meet broad patient and consumer acceptance. However, their full translational potential remains underexplored, particularly with respect to advancement into prescription-grade therapies at well-characterized, safe, and effective dosages. Botanically derived cannabinoid therapeutics, in particular, have the capacity to transform the treatment of pain and neurological conditions. Botanical formulations containing multiple active constituents may engage multiple disease-relevant mechanisms within a single therapeutic product, while enabling a distinct and potentially more streamlined development pathway compared with conventional fixed-dose combination drugs. Regulatory authorities have increasingly recognized the therapeutic potential of botanical drugs. In 2004, the U.S. Food and Drug Administration (FDA) issued its Botanical Drug Development Guidance, later revised in 2016, establishing a formal pathway for the development of regulated botanical therapies, including cannabinoid-based medicines, under rigorous regulatory oversight. While this guidance provides a clear framework, significant challenges remain in its practical application. Key hurdles include the ability to manufacture products with reproducible and well-controlled cannabinoid composition, as well as the need to demonstrate safety and efficacy through well-designed, rigorous preclinical and clinical studies. "Botanically derived cannabinoid medicines originate from complex plant extracts that must be rigorously characterized and controlled," said Dr. Justyna Kulpa, Director of Research and Development at BRC. "At BRC, advancing these products requires tight integration across R&D, manufacturing, CMC, quality, and regulatory functions. This cross-functional collaboration is essential to delivering consistent, standardized medicines and has positioned us to progress our pipeline, including the upcoming clinical evaluation of our third investigational product." BRC's pipeline includes two drug candidates that are currently being tested in clinical trials for Complex Regional Pain Syndrome (CRPS) and Aromatase Inhibitor-Induced Arthralgia (AIIA). Unlike other plant medicines, botanically derived cannabinoid therapeutics require oversight by the Drug Enforcement Administration (DEA), since they may contain delta-9-tetrahydrocannabinol (THC), a psychoactive compound. BRC has been operating in a federally compliant framework under stringent DEA oversight since 2020, holding all required licenses for research and development activities and production under cGMP. Compliance with both the FDA and DEA frameworks is essential to building long-term value of proprietary medicines. "BRC was founded only eight years ago and has marched to the forefront of innovation in cannabinoid medicine development. We have obtained all required licenses, built a state-of-the art facility to produce cGMP grade material, and used it to enter clinical trials, which are well on their way," said George Hodgin, CEO and Founder of BRC Therapeutics. "We realize that the complex field of cannabinoid-based therapy development requires more collaborative efforts across and within sectors than other fields. With this publication, we have supplied a roadmap to provide patients with much needed medicines. We expect this modality to be mainstream in the not too distant future." About BRC Therapeutics BRC Therapeutics (BRC) is a pharmaceutical company focused on developing innovative therapeutics to deliver relief from pain and other symptoms in acute and chronic conditions. BRC's medicines are multimodal and contain cannabinoids at defined ratios. BRC has developed a pipeline of prescription medicines addressing neurological and inflammatory conditions. Two investigational products are currently being tested in clinical trials for Complex Regional Pain Syndrome (CRPS) and Aromatase Inhibitor-Induced Arthralgia (AIIA), respectively. BRC is registered with the Drug Enforcement Administration and is based in Monterey, CA. To learn more about BRC, visit https://brctherapeutics.com/. Forward‑Looking Statements This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks, uncertainties and assumptions, including without limitation statements about the development, use, benefits and effects of BRC Therapeutics' (BRC) therapeutic product candidate and related technology, future plans for the BRC's business and growth, expected plans with respect to clinical trials, including the number of patients enrolled and timing of patient enrollment. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "design," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements. The forward-looking statements made herein speak only as of the date of this press release and, unless otherwise required by law, BRC does not undertake any obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. SOURCE BRC Therapeutics