Weekly Psychedelic News – Week 5, 2023

In a major breakthrough for the medical community, the Therapeutic Goods Administration (TGA) has approved the use of MDMA and psilocybin in Australia. Meanwhile, British Columbia becomes the first province to legalize the possession and use of MDMA. Additionally, Terran Biosciences has published notice of its patent applications covering oral forms of DMT and 5-MeO-DMT, as well as sustained-release MDMA. With states like New Hampshire, Missouri, Washington State, and Arizona proposing legislation for psychedelic legalization and research, this is a rapidly evolving landscape for this sector.

MDMA and psilocybin approved by TGA for medical use in Australia

Within six months, individuals with severe mental health issues will be able to receive prescriptions for the psychedelics MDMA and psilocybin. The Therapeutic Goods Administration approved the change after calls to reclassify the drugs, however, only authorized psychiatrists can prescribe them.

MDMA, commonly referred to as ecstasy or Molly, is a type of psychoactive substance that functions as a stimulant. It works by releasing certain chemicals in the brain, which leads to an increase in energy levels, heightened senses, and heightened emotions such as self-awareness and empathy.

Experts are exploring the potential benefits of MDMA through various trials. The goal is to find effective ways to conduct an MDMA-assisted therapy, particularly for patients suffering from PTSD. 

New Hampshire, Missouri, Washington State, and Arizona Propose Psychedelic Legalization and Research

New Hampshire, Missouri, Washington State, and Arizona are all exploring various measures for psychedelics reform. In New Hampshire, a bill has been introduced to legalize the possession and use of psychedelics for adults 21 and over.

In Missouri, a bill has been filed to provide therapeutic access to psilocybin for people with serious mental health conditions. In Washington State, a bipartisan group of senators has introduced a bill for psychedelic decriminalization. In Arizona, a bipartisan group of lawmakers has filed a bill to allocate $30 million for psilocybin research and study its potential benefits for a range of conditions including anxiety, PTSD, depression, and substance abuse.

British Columbia is the first province to legalize possession and use of MDMA

As of January 31, 2023 until January 31, 2026, individuals who are 18 years and older in British Columbia are permitted to legally possess and use a maximum of 2.5 grams of MDMA. This exemption applies to other hard drugs as well.

The legalization affects hard drugs such as heroin, fentanyl, and cocaine.

This is a three year trial permission by the government, when the drugs will still be illegal but those carrying less than 2.5 grams will not be arrested, charged or have the drugs confiscated.

Small Pharma reveals advancements in its Intellectual Property portfolio with the approval of two new patents.

George Tziras quote about Small Pharma patents

The US Patent and Trademark Office has notified the firm of its permission to grant a patent for US application number 17/680,411. Upon issuance, this patent will grant protection for the composition of a set of deuterated N,N-Dimethyltryptamine (DMT) compounds, as well as therapeutic compositions and usage of the designated compounds.

Terran Biosciences publishes notice of PCT patent filings covering oral versions of DMT and 5-MeO-DMT, as well as sustained-release MDMA.

Terran’s patent applications showcase findings from animal studies that show DMT and 5-MeO-DMT can be taken orally using the company’s unique prodrug method. These psychedelics are considered highly valuable for medical treatment, but they are not effective when taken orally due to liver metabolism.

DMT was previously consumed with a monoamine oxidase (MAO) inhibitor to prevent this metabolic breakdown, but this is not a viable option for widespread use as it may cause side effects like nausea, vomiting, and blood pressure changes.

Psychedelic Market Update – January 30th – February 3rd, 2023

TickerCurrent PriceWeek To DateYear to Date

Pharmala Biotech Holdings INC. ($MDMA) is an early stage drug development and API supply company founded in the belief that MDMA and its analogs represent a monumental opportunity for the treatment of a number of conditions.

Pharmala Biotech was granted an export permit for 300 grams of LaNeo™ MDMA which followed with Australia’s regulatory change to allow prescription of MDMA and Psilocybin sent the stock flying this week.

PharmaTher Holdings Ltd. ($PHRM) is a clinical-stage psychedelics biotech company that focuses on the research, development, and commercialization of novel uses, formulations, and delivery methods of psychedelics to treat mental illness, neurological, and pain disorders. The company’s product in pipeline includes Ketamine intravenous injection, which is in Phase II and III clinical trials for Parkinson’s disease, anesthesia and sedation, and amyotrophic lateral sclerosis indications.

On Thursday PharmaTher announced that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to KETARX™ for the treatment of Rett Syndrome, a rare genetic neurological disorder. Ketamine has been subject to a Phase 2 clinical trial (NCT03633058) for Rett syndrome. Unpublished results from this study will be evaluated to support a potential Phase 3 clinical study and obtain FDA agreement on a regulatory plan for approval. Pharmater gained 35% on the news ending the week 50% higher.

Entheon Biomedical Corp ($ENBI) is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective Dimethyltryptamine based psychedelic therapeutic products (DMT products) for the purposes of treating addiction and substance use disorders.

Cybin Inc. ($CYBN) is a biopharmaceutical company, developing psychedelic-based therapeutics. Some of the developments are CYB003, a deuterated psilocybin analog to treat major depressive and alcohol use disorders; CYB004, a deuterated dimethyltryptamine for treating anxiety disorders; and CYB005, a phenethylamine derivative to treat neuroinflammation. The company also developed EMBARK, a psychedelic-assisted psychotherapy.

On February 1st Cybn announced approval for first-in-human dosing of its Proprietary DMT Molecule CYB004, marking the first-ever trial to evaluate deuterated DMT in humans. The Phase 1 CYB004-E trial is being conducted at the Centre for Human Drug Research in the Netherlands and is the largest ever Phase 1 DMT trial conducted to-date. The stock saw a weekly high of 48 cents and closed at $0.44.

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