MDMA Therapy

A new study published in Scientific Reports revealed that while U.S. healthcare professionals are largely open to the therapeutic potential of psychedelics like psilocybin and MDMA, their understanding of their clinical uses and risks is limited. The research, led by Erin Wang and colleagues from...

Kaya Holdings, Inc. (OTCQB:KAYS), a company engaged in the emerging psilocybin treatment sector and medical/recreational cannabis, has voiced strong criticism of the FDA’s decision to reject MDMA therapy as a treatment for post-traumatic stress disorder (PTSD). KAYS, which operates The Sacred...

The U.S. Food and Drug Administration (FDA) is on the verge of making a historic decision regarding the approval of Lykos Therapeutics MDMA-assisted therapy as a mainstream medical treatment for post-traumatic stress disorder (PTSD). The decision, expected by August 11, could mark a turning point...

In another bipartisan effort, U.S. Senators Michael Bennet (D-Colo.), Thom Tillis (R-N.C.), Kyrsten Sinema (I-Ariz.), and Rand Paul (R-Ky.), along with 15 colleagues called on the U.S. Food and Drug Administration (FDA) to base its upcoming decision on MDMA-Assisted Therapy for Post-Traumatic...

A committee of advisors to the U.S. Food and Drug Administration (FDA) dealt a blow to the burgeoning field of psychedelic medicine by recommending against the approval of MDMA-assisted therapy as a treatment for PTSD. MDMA, also known as ecstasy, has been studied for over a decade as a potential...

Intranasal 5-MeO-DMT Clinical Trial Offers Hope For Treatment-Resistant Depression Partners Beckley Psytech and atai Life Sciences (NASDAQ:ATAI) have jointly announced positive initial results from a Phase 2a study of Beckley’s novel formulation of 5-MeO-DMT in Treatment Resistant Depression...

Providers at Utah's two largest healthcare systems may now treat patients with psilocybin and MDMA as part of a pilot program created by a proposal-turned-law that will take effect as early as May 1, 2024.  The program, open to providers at the University of Utah Health and Intermountain Health,...

Health Canada has approved an amendment to Optimi Health’s (OTCQX: OPTHF) dealer's license, effectively allowing the company to supply MDMA and psilocybin drugs to the country’s Special Access Program (SAP.)  Since Jan. 2022 physicians have been allowed to request...

Cybin One Steps Away From Complete Dosing Cybin (NYSE: CYBN) completed dosing on five of six participant cohorts in its ongoing Phase 2 trial evaluating proprietary deuterated psilocybin analog CYB003 for the treatment of Major Depressive Disorder (MDD). Much like cohort 4, cohort 5 was...

Licensed psychedelic drugs producer Optimi Health Corp. (OTCQX: OPTHF) submitted a Health Canada clinical trial application (CTA) for a Phase 1 study that will assess the safety of combining its natural psilocybin standardized extract with its proprietary MDMA drug candidate in healthy therapists....

Ketamine products manufacturer PharmaTher Holdings Ltd. (OTCQB: PHRRF) had lots happening this past week. Here are the company's top three news items. FDA’s Orphan Drug Status To Ketamine For Rett Syndrome The FDA granted an orphan drug designation to the company’s proprietary...

An increasing number of state lawmakers are aiming to introduce psychedelic legalization bills to their respective House of Representatives and Senates. Let’s take a look at some of the latest proposals. Missouri Bill: Psilocybin Therapy For Qualifying Patients After advising on his...

Health Canada Oks Clinical-Grade MDMA Export To UK Life sciences psychedelics company PharmAla Biotech Holdings Inc. and its manufacturing partners received a Health Canada export permit for no less than 300 grams of proprietary MDMA LaNeo. “We’re incredibly proud of this milestone. It...

Health Canada receives applications concerning clinical trials on a regular basis.  This time, the licensed producer of natural EU-GMP psilocybin and MDMA Optimi Health Corp. (OTCQX: OPTHF) together with ATMA Journey Centers say they intend to submit a Phase I clinical trial...

Optimi Health Corp. (OTCQX: OPTHF) received permission from Health Canada to manufacture and distribute other psychedelic substances -most notably MDMA- under the amended terms outlined in its June 20, 2022 application to the institution. Optimi holds a license to produce...