DEA approval allows Mycrodose Therapeutics to become the first vertically integrated US Pharmaceutical company utilizing psilocybin-based psychedelic medicine. Approval also allows Mycrodose the ability to deepen its control on the US supply-chain, better protect their development of and expansion of Intellectual Property and reduce R&D expenditures by millions of dollars annually.
San Diego, California--(Newsfile Corp. - February 23, 2022) - Mycrodose Therapeutics ("Mycrodose"), a leading US pharmaceutical company specializing in the development of advanced drug delivery systems to treat cancer related conditions, mental health, and cognitive degenerative diseases, announced today the US Drug Enforcement Agency (DEA) and the US Food and Drug Administration (FDA) have approved the company to cultivate Psilocybe cubensis and synthesize five (5) Schedule I compounds under their Schedule I Research License.
"We are so excited that the DEA has granted us approval to synthesize our own APIs and grant us the approval to cultivate Psilocybe Cubensis mushrooms inside our laboratory in California. As far as we've seen, this is the first time a company has ever been approved by the DEA and FDA to cultivate and grow these mushrooms in the United States," says Chad Conner, Chief Executive Officer of Mycrodose Therapeutics. "On behalf of our entire company, I wanted to thank the DEA and FDA for their continued efforts in allowing Mycrodose the ability to further our research into finding alternative ways to help the millions of patients suffering unnecessarily."
Mycrodose Therapeutics' ability to cultivate and synthesize their own active pharmaceutical ingredients (API) saves the company an estimated $2.5MM annually in R&D costs associated with procuring Schedule I drug compounds from approved third-party vendors. More importantly, it allows Mycrodose's Scientific Team the ability to expand and create novel IP as they refine their product manufacturing methods, synthesis and stabilization technologies, enhance extraction technologies, and improve the safety and bioavailability of their core advanced drug delivery (ADD) technologies.
Having the in-house ability to cultivate psilocybin mushrooms and extract specific compounds allows Mycrodose Therapeutics the ability to create and collect a genetic library of Psilocybe cubensis mushrooms and better understand the impact of the other fungi constituents.
"We continue to push our research and product development efforts to even higher levels of scientific integrity and scrutiny. This additional DEA license furthers Mycrodose's vertical integration and widens our foundational capabilities, in particular freeing us from supply-chain constraints. Having access to unique API's produced under cGMP will open our work to further novel intellectual properties along the lines of cultivation, extraction, novel therapeutic indications and associated delivery technologies. We strongly believe that taking this much harder route is the smarter way to grow and protect our intellectual property portfolio. In addition, by keeping this sensitive info and work effort in-house, we will save millions of dollars in R&D costs," says Frank Kochinke, Chief Scientific Officer of Mycrodose Therapeutics.
Mycrodose's advanced drug delivery (ADD) technologies allow for smarter delivery systems that create better safety profiles, enhanced bioavailability, require less active pharmaceutical ingredients, an added convenience and practical use, plus the ability to meet the needs of children and elderly.
About Mycrodose Therapeutics
Mycrodose Therapeutics Inc. is a U.S.-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing DEA Schedule I & III drugs and other compounds to treat cancer related conditions, mental health, and cognitive degenerative diseases. Mycrodose's state-of-the-art laboratory includes a transdermal department with full in-vitro and analytical capacities that allows for all intellectual property and proprietary data to remain in-house. The company believes that its IP-Protected Sustained Microdosing Technology™ is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.
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