Core Viewpoint - MIRA Pharmaceuticals, Inc. announced that its product MIRA-55 is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA), which facilitates its development and commercialization in treating neurologic and neuropsychiatric disorders [2][7][9]. Group 1: Product Overview - MIRA-55 is being investigated for treating adult patients with neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia [3][9]. - Pre-clinical studies indicate that MIRA-55 can improve memory by 100% in wild-type mice, contrasting with THC, which can impair cognitive function [3][4]. Group 2: Market Potential - The company estimates a significant market opportunity with access to a $90 billion traditional neurological market and a $30 billion cannabis market [5]. - Anxiety disorders affect approximately 40 million U.S. adults, while cognitive impairment impacts around 16 million people, indicating a substantial patient population for MIRA-55 [5]. Group 3: Competitive Advantages - MIRA-55 offers a more stable anti-anxiety effect compared to THC, which has a biphasic effect [7]. - The product exhibits lower potency at the CB1 receptor, responsible for psychoactive effects, while maintaining higher activation of the CB2 receptor, suggesting therapeutic benefits with minimal intoxicating effects [7]. - MIRA-55 aims to provide quicker relief and fewer side effects compared to current treatments like SSRIs and SNRIs, which can take weeks to show effects [5][7]. Group 4: Regulatory Status - The DEA's ruling on MIRA-55 provides a regulatory advantage, allowing for more accessible research and development processes compared to marijuana, which is classified as a controlled substance [7][9]. - MIRA Pharmaceuticals also holds exclusive rights for Ketamir-2, another product not classified as a controlled substance, indicating a favorable regulatory environment for its pipeline [8].
Mira Pharmaceuticals Announces DEA Rules MIRA-55, a Novel Oral Pharmaceutical Marijuana Analog, Is Not Classified as a Controlled Substance