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.
MIRA Pharmaceuticals said the U.S. Drug Enforcement Administration has determined that MIRA-55 is not 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.
While THC – the principal psychoactive compound in marijuana – can impair cognitive function, MIRA-55 has demonstrated in pre-clinical studies that it can improve memory by 100% in wild-type mice, according to the company.
In a news release, MIRA asserted that the DEA’s decision “facilitates more accessible research and development processes and reduces legal and logistical barriers to further studies and eventual commercialization.”
“We are thrilled with the DEA’s decision, which underscores the potential of MIRA-55 as a groundbreaking therapeutic candidate,” said Erez Aminov, chairman and CEO of MIRA Pharmaceuticals. “This ruling allows us to focus on MIRA-55’s unique cognitive and anxiety benefits. With access to $90 [billion] traditional neurological and $30 [billion] 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.”
On May 21, the DEA initiated the rulemaking process for its proposal to reschedule marijuana from a Schedule I substance under the Controlled Substances Act to a Schedule III substance. The DEA says the proposed rule is “consistent with the view of the Department of Health and Human Services (HHS) that marijuana has a currently accepted medical use as well as HHS’s views about marijuana’s abuse potential and level of physical or psychological dependence.”
Dr. Itzchak Angel, chief scientific advisor of MIRA Pharmaceuticals, asserted that MIRA-55 “offers a promising alternative” to SSRIs and SNRIS “with the potential for quicker relief and fewer side effects for both anxiety and cognitive impairment.”