Psilocybin could be a real game changer. Not only could it help with depression, anxiety, OCD, opioid addiction, PTSD, and eating disorders, it could help treat those with moderate to severe traumatic brain injury (TBI). In fact, according to Revive Therapeutics Ltd. (CSE:RVV) (OTC:RVVTF), “Approximately 50% of people with severe TBI will experience further decline in their daily lives or die within 9 years of their injury. People with TBI are fifty times more likely to die from seizures and six times more likely to die from pneumonia. Psilocybin has the potential with its neuroreparative effect to improve loss of cognitive function after TBI lessening disability.” That news could also be substantial for companies, such as MindMed (NASDAQ:MNMD)(NEO:MMED), Compass Pathways (NASDAQ:CMPS), Numinus Wellness Inc. (TSXV:NUMI)(OTC:LKYSF), and PharmaTher Holdings Ltd. (CSE: PHRM)(OTCQB: PHRRF).
Revive Therapeutics (CSE:RVV)(OTC:RVVTF) Just Filed for US FDA Orphan Drug Designation
Revive Therapeutics Ltd., a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has filed an application with the U.S. Food and Drug Administration to receive Orphan Drug Designation for Psilocybin to treat moderate to severe traumatic brain injury.
There are no FDA approved treatments for cognitive impairments due to TBI. Moderate to severe TBI is a subset of TBI and can lead to a physical, cognitive, emotional, and behavioral changes over the course of a person’s life. These changes may affect a person’s ability to function in their everyday life. Approximately 50% of people with severe TBI will experience further decline in their daily lives or die within 9 years of their injury. People with TBI are fifty times more likely to die from seizures and six times more likely to die from pneumonia.
Psilocybin offers a potential solution to manage moderate to severe cases of TBI. Psilocybin has the potential with its neuroreparative effect to improve loss of cognitive function after TBI lessening disability. The clinical effect of psilocybin appears to be related to its attenuation of traumatically-induced glutamate excitotoxicity during the early post-injury period. In preclinical studies conducted at the National Health Research Institutes, which was part of the research program acquired from PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF), characterized the potential neuroreparative effect of psilocybin compared to being treated with a vehicle (saline) using a TBI mouse model. Adult mice were randomly assigned to 4 groups: (1) control, (2) TBI+vehicle, (3) TBI+low dose psilocybin, and (4) high dose psilocybin. Cognitive function was examined by the Morris water maze test after the injury. It was found that psilocybin, given after injury, improved cognitive function in TBI mice. Also, there were no adverse effects observed with psilocybin.
Michael Frank, CEO of Revive commented: “The FDA orphan drug application for psilocybin to treat moderate to severe TBI is an important milestone for Revive as we focus on building a robust product pipeline focused on novel uses and delivery forms of psilocybin to treat significant unmet medical needs. We are currently seeking to evaluate psilocybin in a clinical trial for moderate to severe TBI and advancing our development of a proprietary oral thin film psilocybin product for the potential treatment of certain neurological disorders, such as brain damage caused by all forms of TBI and stroke, and other related mental health and substance abuse disorders.”
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify psilocybin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.
Other related developments from around the markets include:
MindMed, a leading psychedelic medicine biotech company, is pleased to announce the start of trading on The Nasdaq Capital Market. Trading will begin on Tuesday, April 27 under the symbol "MNMD." As a reminder, MindMed will retain its listing on the Neo Exchange Inc. under the symbol "MMED". Once trading begins, the Company's subordinate voting shares will convert from the OTCQB under the symbol "MMEDF" to the new symbol "MNMD".
Compass Pathways, a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, welcomed a study published in the New England Journal of Medicine (NEJM) yesterday, which showed signals of positive activity in COMP360 psilocybin compared with the standard antidepressant escitalopram, for major depressive disorder (MDD). The study was designed and conducted by a research team at Imperial College London, using COMPASS’s COMP360 psilocybin.
Numinus Wellness Inc., a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, announced that it has formed a partnership with KGK Science, a leading contract research organization with expertise in natural products, to undertake a new Psilocybin extraction clinical trial. The Phase 1 trial will enroll 14 human volunteers and assess the safety and psychoactive properties of a Psilocybe mushroom product extracted and formulated at the Numinus Bioscience lab in British Columbia, Canada. Successful completion of the landmark trial would result in safety and efficacy data for a natural Psilocybin product which could subsequently be used for further research and government-approved special access or compassionate access programs.
PharmaTher Holdings Ltd. a specialty psychedelic pharmaceutical company, announced that it has filed a provisional patent application with the U.S. Patent and Trademark Office outlining the novel use of ketamine as a potential treatment for Type 2 diabetes and obesity, based on the evaluation of the Company’s drug repurposing artificial intelligence (“AI”) platform, panaceAI™. PharmaTher is also advancing research with panaceAI™ to evaluate repurposing opportunities with N,N-Dimethyltryptamine (“DMT”), 3,4-Methylenedioxymethamphetamine (“MDMA”) and lysergic acid diethylamide (“LSD”) for future clinical development and partnering opportunities.
Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Winning Media is only compensated for its services in the form of cash-based compensation. Pursuant to an agreement Winning Media has been paid three thousand five hundred dollars for advertising and marketing services for Revive Therapeutics Ltd. by Revive Therapeutics Ltd. We own ZERO shares of Revive Therapeutics Ltd. Please click here for full disclaimer.
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