MDMA

Optimi Health Granted Precursor Licence To Formulate MDMA And Completes Encapsulation Of 40mg And 60mg Dosage Formats

Retrieved on: 
Wednesday, January 3, 2024

"Securing our precursor licence represents a pivotal advantage for Optimi, offering a compelling edge in producing MDMA at significantly reduced costs," said Optimi Chief Financial Officer Jacob Safarik.

Key Points: 
  • "Securing our precursor licence represents a pivotal advantage for Optimi, offering a compelling edge in producing MDMA at significantly reduced costs," said Optimi Chief Financial Officer Jacob Safarik.
  • "With the AMA’s current procedural terminology ("CPT") III codes for psychedelic-assisted therapies now officially in effect, this underscores the goal of obtaining our precursor licence.
  • With the Company’s precursor licence secured, Optimi Chief Science Officer, Dr. Preston A.
  • Chase, is pleased to report the successful encapsulation of MDMA into 40mg and 60mg dosage formats after verification through its High-performance Liquid Chromatography (HPLC) methodology.

A brief history of drug-fuelled combatants

Retrieved on: 
Tuesday, January 2, 2024

I don’t know whether he thought that it might reduce pain or improve performance, but the idea of taking drugs before “going into battle” goes back to the beginning of recorded history.

Key Points: 
  • I don’t know whether he thought that it might reduce pain or improve performance, but the idea of taking drugs before “going into battle” goes back to the beginning of recorded history.
  • Indeed, we find frequent mentions of mead drinking by the warriors in Edinburgh in the seventh-century epic poem The Goddodin.
  • These ancient warriors probably used alcohol to reduce anxiety and blunt the horrors they would face on the battlefield.
  • Pervitin (methamphetamine) was given almost freely to all arms of the German war machine.
  • The frontline Nazis called them Panzerschokolade (tank chocolate), due to the feelings of incredible strength and invincibility that the pills gave them.

Behavioural effects


The types of drugs taken by warriors can be lumped into three broad categories: depressants, hallucinogens and stimulants. Alcohol is a depressant that calms the nerves by reducing brain activity. Psychedelic mushrooms such as Amanita muscaria contain a variety of psychoactive substances. Hyoscyamus niger also has a variety of active compounds that cause hallucinations and, importantly, aggressive and combative behaviour.

  • The word “groggy” meaning dazed and unsteady came from British navy sailors exhibiting this behaviour after their daily ration of rum and water (grog).
  • The stimulants, but especially methamphetamine, would also lead to significant weight loss even after only a few days of use.
  • Long-term use, as we saw with the Nazis, would probably lead to emaciated soldiers.

Smart drugs

  • We have seen that soldiers take drugs before battles to calm nerves, deal with the horrors, reduce pain, tolerate lack of food and sleep and improve alertness.
  • The stimulants include drugs such as amphetamine salt mixtures, methylphenidate and modafinil, while nootropics include piracetam, caffeine, cobalamin (vitamin B12), guarana, pyridoxine (vitamin B6) and vinpocetine.
  • The integration of humans, technology and machines is thought to be the future of warfare and drugs that facilitate this are undoubtedly being researched by the military.

Post-traumatic stress disorder

  • There is a long history of soldiers taking alcohol and other drugs to deal with the horrors of what they have seen, or the disappointment of life after leaving the army.
  • These veterans are taking MDMA and psilocybin on doctors’ orders as part of their treatment for PTSD.
  • Ketamine is useful for treating depression and LSD is also being tested for various psychiatric disorders.


Colin Davidson has previously received funding from the US National Institute on Drug Abuse (NIDA). He is a consultant with the Defence Science and Technology Laboratory (UK).

MAPS PBC Announces New American Medical Association CPT III Codes for Psychedelic-Assisted Therapies Take Effect

Retrieved on: 
Tuesday, January 2, 2024

SAN JOSE, Calif., Jan. 2, 2024 /PRNewswire/ -- MAPS Public Benefit Corporation ("MAPS PBC"), a clinical-stage company dedicated to changing the way mental health conditions are treated, announced that the American Medical Association ("AMA") current procedural terminology ("CPT") III codes for psychedelic-assisted therapies, first announced in July 2023, are now in effect. The new CPT codes will provide physicians and other qualified healthcare providers a means to seek coverage and reimbursement for delivering psychedelic-assisted therapy if approved by the U.S. Food and Drug Administration ("FDA").

Key Points: 
  • SAN JOSE, Calif., Jan. 2, 2024 /PRNewswire/ -- MAPS Public Benefit Corporation ("MAPS PBC"), a clinical-stage company dedicated to changing the way mental health conditions are treated, announced that the American Medical Association ("AMA") current procedural terminology ("CPT") III codes for psychedelic-assisted therapies, first announced in July 2023, are now in effect.
  • MAPS PBC and COMPASS Pathways collaborated to work with the AMA to create these new CPT III codes.
  • On March 3, 2023, the AMA published the Summary of Panel Actions which included the acceptance of the new CPT III codes.
  • With Breakthrough Therapy designation given to MDMA in 2017, MAPS PBC has requested the FDA grant Priority Review of the NDA.

atai Life Sciences Announces Positive Topline Results from Single Ascending Dose Phase 1 Study with EMP-01 (R-MDMA)

Retrieved on: 
Tuesday, January 2, 2024

The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01.

Key Points: 
  • The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EMP-01.
  • The four-cohort, single-ascending dose, randomized, double-blind, placebo-controlled study enrolled 32 healthy participants who received 75mg, 125mg, 175mg or 225mg of EMP-01 or placebo in a 6+2 design.
  • There were no study discontinuations, and no serious or severe AEs were observed in the study.
  • Detailed clinical data from the Phase 1 study of EMP-01 are expected to be presented at a future medical meeting.

PharmAla Files Audited Financials for Year Ending August 31, 2023

Retrieved on: 
Friday, December 29, 2023

- PharmAla’s LaNeo™ GMP Drug Product was submitted and allowed for clinical trial use by the USFDA; PharmAla is currently supporting over 10 clinical trials globally with LaNeo.

Key Points: 
  • - PharmAla’s LaNeo™ GMP Drug Product was submitted and allowed for clinical trial use by the USFDA; PharmAla is currently supporting over 10 clinical trials globally with LaNeo.
  • “This has been an exciting year for PharmAla, and for MDMA more broadly,” said Nick Kadysh, CEO, PharmAla Biotech.
  • We are excited to continue to build off of the milestones we achieved at PharmAla in 2023.
  • The recent filing of the MAPS New Drug Application for MDMA-Assisted Therapy for PTSD provides a favourable industry tailwind.

Sight Sciences Announces Withdrawal of Final LCDs on Micro-Invasive Glaucoma Surgery from Five Medicare Administrative Contractors

Retrieved on: 
Thursday, December 28, 2023

MENLO PARK, Calif., Dec. 28, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences”), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients’ lives, supports the decision announced by five Medicare Administrative Contractors (“MACs”) to withdraw their final local coverage determinations (“LCDs”) for Micro-Invasive Glaucoma Surgery (“MIGS”) that were scheduled to take effect on January 29, 2024.

Key Points: 
  • MENLO PARK, Calif., Dec. 28, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences”), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients’ lives, supports the decision announced by five Medicare Administrative Contractors (“MACs”) to withdraw their final local coverage determinations (“LCDs”) for Micro-Invasive Glaucoma Surgery (“MIGS”) that were scheduled to take effect on January 29, 2024.
  • All five MACs have now issued statements that the final LCDs will not go into effect on January 29, 2024.
  • As a result, there will be no change in January 2024 to the current Medicare coverage for MIGS procedures performed with the OMNI Surgical System.
  • Additionally, we appreciate the support from the Medical Device Manufacturers Association (MDMA) and numerous patient advocacy groups.”

Clarion Clinics Receives Ethics Board Endorsement for the First Dedicated Psychedelic-Assisted Therapy Clinic in Australia

Retrieved on: 
Thursday, December 21, 2023

MELBOURNE, Australia and NEW YORK, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (‘Incannex’ or ‘the Company’) a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs is pleased to announce that it has received ethics board endorsement for psychedelic assisted therapy at its first clinic based in Melbourne, Australia, a city of approximately 5.2M people.

Key Points: 
  • Incannex subsidiary, Clarion Clinics, has received Human Research Ethics Committee (HREC) endorsement for administration of psychedelic-assisted therapies for TRD and PTSD.
  • Clarion Clinics is the only dedicated psychedelic-assisted therapy clinic in Australia, with intentions to open more clinics across the country and internationally as legislation permits.
  • Clarion Clinics team includes pre-eminent psychedelic researchers, psychologists and psychiatrists whose expertise can not easily be replicated in Australia.
  • The Melbourne Clarion Clinic will be the first dedicated Psychedelic-assisted therapy clinic in Australia.

Beckley Academy Welcomes New Faculty for 2024 Psychedelic Therapy Practitioners Courses

Retrieved on: 
Thursday, December 14, 2023

Both Sara and Mary are psychedelic therapists with clinical experience working with training organizations to meet the increasing demand for experienced and credentialed therapists able to train practitioners in the administration and facilitation of psychedelic therapies.

Key Points: 
  • Both Sara and Mary are psychedelic therapists with clinical experience working with training organizations to meet the increasing demand for experienced and credentialed therapists able to train practitioners in the administration and facilitation of psychedelic therapies.
  • Mary has completed training at CIIS CPTR, MAPS, and the Ketamine Training Center and is certified in Trauma-Focused Cognitive Behavioral Therapy.
  • Sara Gael Beauregard, MA, LPC, is a psychedelic therapist, educator, and mentor with expertise in MDMA-Assisted Therapy, ketamine-assisted therapy, and psychedelic risk reduction.
  • At Beckley Academy, we foster the relationship between learners and faculty by approaching the online classroom as a time for rich discussion, reflection, and embodied skills practice,” said Deborah Gardner , Head of Education for Beckley Academy.

Optimi Health and Sunshine Earth Labs Ltd. Forge Strategic Supply Agreement

Retrieved on: 
Thursday, December 7, 2023

VANCOUVER, British Columbia, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi”), a licensed Canadian drug researcher and formulator specializing in controlled psychedelic substances such as natural psilocybin and MDMA, today announced the signing of a supply agreement with Sunshine Earth Labs Ltd. (“Sunshine Labs”), a fellow British Columbia-based biosciences company licensed by Health Canada.

Key Points: 
  • VANCOUVER, British Columbia, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi”), a licensed Canadian drug researcher and formulator specializing in controlled psychedelic substances such as natural psilocybin and MDMA, today announced the signing of a supply agreement with Sunshine Earth Labs Ltd. (“Sunshine Labs”), a fellow British Columbia-based biosciences company licensed by Health Canada.
  • This strategic collaboration marks a significant milestone for both Optimi and Sunshine Labs, who share a commitment to ensuring a secure global supply of GMP quality-controlled substances for medicinal and research purposes.
  • Optimi CEO, Bill Ciprick, says the partnership will forge a formidable alliance as both companies leverage their points of access in the highly regulated psychedelics market.
  • Donovan Edwards, CEO of Sunshine Labs, echoes the sentiment, saying, "Our partnership with Optimi solidifies our commitment to delivering a safe and secure supply of controlled substances globally.

Mydecine Announces Update Regarding the Special Access Program

Retrieved on: 
Tuesday, November 28, 2023

DENVER, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Mydecine Innovations Group Inc. (“Mydecine” or the “Company”) (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) a biotechnology company engineering the next wave of innovative medications and treatment protocols to directly address mental health with a particular emphasis on addiction and PTSD, wishes to clarify certain statements made in the Company’s news release of January 13, 2022 (the “Prior Release”) wherein the Company announced it would be launching the Special Access Support and Supply Program (“SASSP”) to provide products and services to physicians, clinics, and hospitals in Canada who are looking to treat patients through psychedelic-assisted psychotherapy.

Key Points: 
  • DENVER, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Mydecine Innovations Group Inc. (“Mydecine” or the “Company”) (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) a biotechnology company engineering the next wave of innovative medications and treatment protocols to directly address mental health with a particular emphasis on addiction and PTSD, wishes to clarify certain statements made in the Company’s news release of January 13, 2022 (the “Prior Release”) wherein the Company announced it would be launching the Special Access Support and Supply Program (“SASSP”) to provide products and services to physicians, clinics, and hospitals in Canada who are looking to treat patients through psychedelic-assisted psychotherapy.
  • The Company would like to clarify that the access to Health Canada’s Special Access Program (the “Program”) to assist potential patients with the use of Psilocybin and/or MDMA is exclusively through its partner, Applied Pharmaceutical Innovation (“API”) pursuant to the Health Canada license granted to Dr. Raimar Loebenberg (the “Partnership”).
  • Pursuant to the Partnership, API may provide patients access to certain controlled substances, including Psilocybin and/or MDMA, however, Mydecine does not directly have the ability to grant patients access to controlled substances through the Program.
  • The Company wishes to further clarify that any previous references to the Program in its press release, social media or website was not intended to promote the availability of unauthorized drugs to Canadians, nor to suggest that these unauthorized drugs have any authorized therapeutic uses in Canada.