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Mira Pharmaceuticals Announces DEA Rules MIRA-55, a Novel Oral Pharmaceutical Marijuana Analog, Is Not Classified as a Controlled Substance

Ruling removes potential complications for manufacturing, pre-clinical development, IND submission, clinical development, and ultimately commercialization.

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Summation

  • Unlike THC found in marijuana, which exhibits a biphasic effect (anti-anxiety at low doses and pro-anxiety at high doses), MIRA55 demonstrates a monophasic dose-response in pre-clinical models, indicating a more stable and consistent anti-anxiety effect across its dosage range.
  • The DEA’s ruling confirms that MIRA-55 is not a controlled substance, offering a significant regulatory advantage over marijuana, which is currently classified as a Scheduled drug.
  • MIRA) (“MIRA” or the “Company”), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, announced that MIRA-55, has been determined by the U.

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, announced that MIRA-55, has been determined by the U.S. Drug Enforcement Administration (DEA) not to be a controlled substance or listed chemical under the Controlled Substance Act and its governing regulations.

MIRA-55 is under investigation for treating adult patients suffering from neuropathic pain as well as anxiety and cognitive decline often associated with early-stage dementia. Unlike THC (the principal psychoactive compound in marijuana), which can impair cognitive function, MIRA-55 has demonstrated in pre-clinical studies that it can improve memory by 100% in wild-type mice.

Key Advantages of MIRA-55 Over Marijuana:

  • Non-Controlled Substance: The DEA’s ruling confirms that MIRA-55 is not a controlled substance, offering a significant regulatory advantage over marijuana, which is currently classified as a Scheduled drug.  This status facilitates more accessible research and development processes and reduces legal and logistical barriers to further studies and eventual commercialization.
  • Cognitive Enhancement: MIRA-55 has shown promising results in enhancing memory and cognitive performance in preclinical models. This is in stark contrast to marijuana, which is known to impair cognition and memory. Long-term marijuana use can impair thinking, memory, and learning functions, particularly when usage begins in adolescence. Studies have shown that heavy marijuana users can experience significant I.Q. declines and cognitive deficits.
  • Stable Anti-Anxiety Effects: Unlike THC found in marijuana, which exhibits a biphasic effect (anti-anxiety at low doses and pro-anxiety at high doses), MIRA55 demonstrates a monophasic dose-response in pre-clinical models, indicating a more stable and consistent anti-anxiety effect across its dosage range. Furthermore, marijuana use has been linked to mental health problems such as depression, anxiety, and an increased risk of psychosis and schizophrenia. Higher THC levels in modern marijuana strains increase the risk of addiction, heart problems, and lung issues.
  • Reduced Intoxicating Effects: MIRA-55 exhibits lower potency at the CB1 receptor, which is responsible for the psychoactive effects of THC, while maintaining higher activation of the CB2 receptor. This suggests that MIRA-55 may deliver therapeutic benefits with minimal intoxicating effects. Unlike marijuana, MIRA-55 aims to provide these benefits without the associated adverse effects such as temporary hallucinations, paranoia, and exacerbating symptoms in patients with schizophrenia.

“We are thrilled with the DEA’s decision, which underscores the potential of MIRA-55 as a groundbreaking therapeutic candidate,” said Erez Aminov, Chairman & CEO of MIRA Pharmaceuticals. “This ruling allows us to focus on MIRA-55’s unique cognitive and anxiety benefits. With access to $90B traditional neurological and $30B cannabis markets, MIRA-55 represents a significant value proposition for our company.  We remain committed to advancing it through the development pipeline for treating these diseases from which so many currently suffer.”

“Anxiety disorders affect around 40 million U.S. adults, causing excessive apprehension, worry, fear, nervousness, physical symptoms like sweating, shortness of breath, and palpitations,” said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals. “Current treatments such as SSRIs and SNRIs can take weeks to work and are associated with side effects. Cognitive impairment, affecting 16 million people (about the population of New York) in the U.S., similarly lacks effective treatments. MIRA-55 offers a promising alternative

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