Psychedelics

LOS ANGELES- Silo Pharma Inc. a developmental-stage biopharmaceutical company, announced that its investigational ketamine implant, SP-26, met all primary endpoints in a preclinical study targeting fibromyalgia. The study, conducted in minipigs, assessed the implant's safety, tolerability, and pharmacokinetics. Study Findings The SP-26 implant demonstrated a favorable safety profile, with no implant-related adverse events observed. Animals maintained stable body weight and normal neurological behavior throughout the study period. The implant achieved sustained systemic ketamine exposure for up to 22 days, with peak plasma concentrations reached within one hour post-implantation. Minimal to mild chronic inflammation was noted at the implant sites, with no dose-dependent differences observed. SP-26 is a subcutaneous, extended-release ketamine ...

LOS ANGELES- Red Light Holland Corp, an Ontario-based producer of psilocybin truffles, announced that its U.S. partner, Irvine Labs, has received a Controlled Substances Import Permit from the Drug Enforcement Administration (DEA). This authorization allows the importation of 3 kilograms of raw psilocybin truffles from the company's facility in Horst, Netherlands, to Irvine Labs' FDA-compliant and DEA-registered facility in California. The imported truffles will be utilized in the development of extended shelf-life microdosing capsules. These capsules are intended for emerging markets and potential inclusion in government-funded pilot programs and clinical trials within the United States. The collaboration aims to establish standardized products derived from naturally occurring psilocybin. Irvine Labs, established ...

LOS ANGELES- The integration of cannabis into psychedelic-assisted psychotherapy is gaining attention as a potential treatment for various mental health conditions, including post-traumatic stress disorder (PTSD), depression, and anxiety. This approach involves administering cannabis in controlled settings, often accompanied by therapeutic guidance, music, and specific lighting to facilitate introspection and emotional processing. Some practitioners report that certain cannabis strains can induce experiences comparable to those elicited by traditional psychedelics like psilocybin or MDMA. Therapeutic Applications and Considerations In therapeutic contexts, cannabis is utilized to assist patients in exploring traumatic memories and emotional challenges. The substance's effects are influenced by factors such as dosage, strain composition, and the individual's psychological state. ...

LOS ANGELES- Cybin Inc. a neuropsychiatry company, has announced a collaboration with Thermo Fisher Scientific to support the Phase 3 clinical supply and potential commercial manufacturing of CYB003, its proprietary deuterated psilocin analog, for the adjunctive treatment of Major Depressive Disorder (MDD). Manufacturing Agreement Details Under the agreement, Thermo Fisher will provide both the drug substance and capsule drug product for CYB003. Manufacturing activities will be conducted at Thermo Fisher’s pharmaceutical services sites in Florence, South Carolina, and Cincinnati, Ohio. This partnership expands upon the existing relationship between the two companies and aligns with Cybin’s strategy to establish domestic manufacturing infrastructure as it advances toward commercialization. CYB003 received Breakthrough Therapy ...

LOS ANGELES- Silo Pharma Inc. a developmental-stage biopharmaceutical company, has commenced a 7-day safety and toxicology study for its lead candidate, SPC-15, an intranasal treatment targeting post-traumatic stress disorder (PTSD). The study is being conducted at Frontage Laboratories, a contract research organization, to gather additional data in support of an upcoming Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) . SPC-15 is designed as a serotonin 5-HT4 receptor agonist, administered intranasally, intended for the treatment of stress-induced psychiatric disorders such as PTSD and anxiety. The drug's development is being carried out in collaboration with Columbia University, which has granted Silo Pharma an exclusive global license ...

LOS ANGELES- atai Life Sciences has commenced a Phase 2 clinical trial evaluating EMP-01, an oral formulation of R-3,4-methylenedioxy-methamphetamine (R-MDMA), for the treatment of social anxiety disorder (SAD). The first patient has been dosed in this exploratory, randomized, double-blind, placebo-controlled study, which aims to assess the safety, tolerability, and efficacy of EMP-01 in approximately 60 adult participants diagnosed with SAD. Participants in the trial will receive two administrations of either EMP-01 or a placebo, spaced four weeks apart. Symptoms will be monitored over a six-week period following the initial dose. The primary objective is to evaluate the safety and tolerability of EMP-01, with secondary objectives including the assessment of improvements ...

LOS ANGELES- Cybin Inc. a neuropsychiatry company, announced that its Chief Executive Officer, Doug Drysdale, will participate in a panel discussion at the 28th Annual Milken Institute Global Conference. The panel, titled "The Global Landscape and Opportunities for Medical Breakthroughs," is scheduled for May 5, 2025, at 2:30 p.m. PDT at the Beverly Hilton in Los Angeles. The conference, running from May 4 to May 7, 2025, convenes leaders from various sectors to address pressing global challenges and explore innovative solutions. Cybin's participation underscores its commitment to advancing mental healthcare through the development of novel treatment options. Cybin is currently progressing its lead candidate, CYB003, a deuterated psilocin analog, into ...

LOS ANGELES- Recent studies indicate a significant increase in psilocybin use across the United States, correlating with evolving public attitudes and regulatory developments. Data from the University of Colorado Anschutz Medical Campus and Rocky Mountain Poison and Drug Safety reveal that lifetime psilocybin use among U.S. adults rose from 10% in 2019 to 12.1% in 2023, equating to over 31 million individuals. Past-year usage also climbed, with 3.1% of adults reporting consumption in 2023, up from previous years. ​ Demographic Trends The increase is particularly notable among adults aged 18 to 29, with past-year use rising by 44% to 2.1% in 2023. Adults aged 30 and above experienced a 188% ...

LOS ANGELES- A recent study published in JAMA Network Open has identified 57 psilocybin dispensaries operating across 35.7% of major Canadian urban centers as of May 2024. The majority of these establishments are located in Ontario and British Columbia, provinces that collectively represent 52.5% of Canada's population. The study highlights that many of these dispensaries are making unsubstantiated health claims regarding psilocybin's efficacy in treating various mental health conditions. Specifically, approximately 81.8% of the dispensaries' websites suggest that psilocybin can alleviate social anxiety and generalized anxiety disorder, while 77.3% claim significant reductions in depressive symptoms. These assertions lack robust scientific validation, raising concerns among health professionals about potential misinformation. Despite ...

LOS ANGELES- Efforts to reform psilocybin laws are accelerating nationwide, with several states making significant strides toward decriminalization or legalization of the psychoactive compound found in "magic mushrooms."​ In Colorado, voters approved Proposition 122 in November 2022, legalizing psilocybin and establishing treatment centers for its supervised use. By June 2023, however, concerns arose over a burgeoning gray market, prompting legislative measures to regulate the advertisement and sale of psychedelic substances. Senate Bill 23-290, effective July 1, 2023, aims to curb unlicensed activities related to psilocybin. ​ California has seen multiple legislative attempts to decriminalize psychedelics. In September 2023, Senate Bill 58, which sought to decriminalize the possession and use of ...

LOS ANGELES- The New Mexico Senate has approved the Medical Psilocybin Act (Senate Bill 219), a bipartisan initiative aimed at establishing a regulated program for the therapeutic use of psilocybin, the psychoactive compound found in certain mushrooms. The bill, which received a 33-4 vote, now awaits consideration in the House of Representatives.​ If enacted, the legislation would permit licensed clinicians to administer psilocybin to patients diagnosed with qualifying conditions, including treatment-resistant depression, post-traumatic stress disorder (PTSD), substance use disorders, and end-of-life psychological distress. The program would involve a structured approach comprising preparation, administration, and integration sessions to ensure patient safety and therapeutic efficacy. ​ The bill also proposes the creation ...

LOS ANGELES- A group of Vermont state senators has introduced Senate Bill 106 (S.106), aiming to extend and expand the scope of the existing Psychedelic Therapy Advisory Working Group. The bill proposes to continue the group's tenure, add new members, and broaden its mandate to further explore the potential of psychedelic-assisted therapies within the state. ​ Background In 2024, the Vermont Legislature established the Psychedelic Therapy Advisory Working Group through Act 126. The group's mission was to review existing research on the benefits and risks of clinical psychedelic-assisted treatments and to assess the feasibility of a state program permitting health care providers to administer such therapies. ​ The working group ...

LOS ANGELES- The New Mexico Senate Judiciary Committee has approved Senate Bill 219, known as the Medical Psilocybin Act, which proposes the establishment of a regulated program for the therapeutic use of psilocybin. This approval marks the bill's progression through its third Senate committee. ​ Introduced by a bipartisan group of legislators, including Senators Jeff Steinborn (D) and Craig Brandt (R), the bill aims to provide psilocybin-assisted therapy for patients with qualifying medical conditions such as major treatment-resistant depression, post-traumatic stress disorder (PTSD), substance use disorders, and end-of-life care. The Department of Health would oversee the program, establishing guidelines for clinician training, dosage, approved administration settings, and safety protocols. The ...

LOS ANGELES- Arizona legislators have approved measures to promote research into the medical applications of psilocybin, the active compound in certain mushrooms, and to establish a Psilocybin Research Advisory Council. The House Military Affairs & Public Safety Committee unanimously passed House Bill 2486, allocating $30 million over three years for clinical trials investigating psilocybin's potential in treating conditions such as post-traumatic stress disorder, depression, anxiety, and substance use disorders. The proposed research emphasizes the use of whole mushroom psilocybin cultivated under a Schedule I license from the U.S. Drug Enforcement Administration. Priority will be given to studies involving veterans, first responders, frontline healthcare workers, and individuals from underserved communities. The ...

LOS ANGELES- Denver's Department of Excise and Licenses has proposed regulations to oversee psilocybin-based wellness facilities, including yoga studios and social clubs, following Colorado's 2022 voter-approved measure legalizing natural medicines like psilocybin. The proposed regulations require these facilities to obtain both state and local licenses, with application and annual renewal fees set at $100 each. Facilities must maintain a 1,000-foot distance from childcare centers and schools. The Denver City Council is scheduled to vote on these regulations on February 24. ​ Some businesses, such as Lyman Support Centers, have been operating in a legal gray area by offering psilocybin mushrooms under the guise of natural medicine. Despite investigations, no charges ...

LOS ANGELES- The psychedelics sector is undergoing significant transformations due to evolving regulatory policies and scientific advancements that could redefine their therapeutic applications. A notable development occurred in August 2024 when the U.S. Food and Drug Administration (FDA) declined approval for MDMA-assisted therapy for post-traumatic stress disorder (PTSD), citing the need for additional research to substantiate its safety and efficacy. In contrast, Australia has taken a more progressive stance. Since July 1, 2023, authorized psychiatrists in the country have been permitted to prescribe MDMA for PTSD and psilocybin for treatment-resistant depression, provided they receive approval from the Therapeutic Goods Administration (TGA) and an ethics committee. These regulatory decisions have immediate ...

LOS ANGELES- In January 2025, Colorado began accepting applications for psilocybin-related business licenses, following the approval of regulations by the Department of Regulatory Agencies and the Department of Revenue. These licenses encompass roles such as facilitators, healing centers, cultivation facilities, product manufacturers, and testing laboratories. The first licensed healing centers are anticipated to commence operations by late spring or early summer 2025. The state's regulatory framework mandates that psilocybin services be conducted within licensed facilities under the supervision of trained facilitators. Unlike cannabis dispensaries, the retail sale of psilocybin for off-site consumption remains prohibited. All psilocybin products must be consumed on-site during guided sessions to ensure participant safety and compliance ...

LOS ANGELES- The Government of Canada, through the Canadian Institutes of Health Research (CIHR), has committed nearly $3 million to fund three clinical trials investigating psilocybin-assisted psychotherapy as a treatment for various mental health and substance use disorders. Funded Clinical Trials: Psilocybin-Assisted Existential, Attachment, and Relational Therapy for Advanced Cancer Patients: Led by Dr. Sarah Hales at the University of Toronto, this trial focuses on alleviating end-of-life psychological distress in patients with advanced-stage cancer. Mechanisms Supporting Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder: Conducted by Dr. Leah Mayo at the University of Calgary, this study examines the safety and efficacy of psilocybin in treating alcohol use disorder. Psilocybin-Assisted Psychotherapy for Treatment-Resistant ...

LOS ANGELES- Atai Life Sciences has announced favorable outcomes from a Phase 2a open-label study evaluating BPL-003, an intranasal formulation of 5-MeO-DMT benzoate, in patients with moderate to severe alcohol use disorder (AUD). The study involved 12 participants who received a single dose of BPL-003 in conjunction with relapse prevention cognitive behavioral therapy. The findings revealed significant and sustained reductions in alcohol consumption over a 12-week period. Notably, 50% of the participants maintained complete abstinence throughout the study duration. BPL-003 was well-tolerated, with only mild to moderate adverse events reported, and no serious or severe adverse events occurred. Most patients were ready for discharge approximately two hours post-administration. These results ...

LOS ANGELES- Awakn Life Sciences Corp. a biotechnology company, has reported progress in its research and development programs targeting Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). AWKN-001: This investigational therapy combines intravenous ketamine with cognitive behavioral therapy (CBT) for severe AUD. Currently in a Phase 3 trial in the UK, co-funded by the UK's Medical Research Council and the National Institute for Health and Care Research, Awakn's financial commitment is capped at £800,000. The company aims for a Regulation 52b hybrid application in the UK, potentially granting up to 10 years of market exclusivity upon approval. AWKN-002: This program involves a proprietary oral thin film formulation of esketamine, ...

LOS ANGELES- In January 2025, Rhode Island lawmakers introduced House Bill 5186, aiming to legalize psilocybin possession and cultivation for personal use. The bill proposes that individuals be allowed to cultivate psilocybin within their residences for personal use. Additionally, contingent upon the U.S. Food and Drug Administration (FDA) rescheduling psilocybin and expanding its access program, the Rhode Island Department of Health would be mandated to establish rules and regulations for its cultivation, distribution, and medical prescription. This legislative effort reflects a growing trend in the United States to reevaluate the legal status of certain psychedelics, particularly in the context of their potential therapeutic benefits. The bill's progression will depend on ...

LOS ANGELES- A coalition of healthcare professionals, academics, and advocates has initiated the PsychedeliCare European Citizens' Initiative (ECI), aiming to enhance access to psychedelic-assisted therapies across the European Union. The campaign seeks to collect one million signatures from at least seven EU member states by January 2026, compelling the European Commission to consider legislative action. The initiative's objectives include establishing standardized guidelines for the safe use of psychedelics in therapeutic settings, increasing EU funding for research into psychedelic therapies, and adopting a unified stance on the legal classification of psychedelics at the international level. Proponents argue that these measures could address the stagnation in psychiatric treatment innovation and provide effective ...

LOS ANGELES- Colorado lawmakers have introduced House Bill 25-1063, a bipartisan proposal that would permit the prescription of crystalline polymorph psilocybin—a synthetic form of the psychedelic compound—contingent upon approval by the U.S. Food and Drug Administration (FDA). The bill, sponsored by Representatives Anthony Hartsook (R) and Kyle Brown (D), aims to provide healthcare providers with an additional treatment option for patients experiencing conditions such as post-traumatic stress disorder (PTSD) and treatment-resistant depression. Representative Hartsook, a combat veteran, emphasized the potential benefits for veterans, stating, "This bill is about a prescription-level medication that's a derivative... designed to treat veterans or anybody that has PTSD, a traumatic brain injury, depression that hasn't ...

LOS ANGELES- Recent studies indicate that psilocybin-assisted psychotherapy may alleviate depression among healthcare professionals affected by the COVID-19 pandemic. A randomized clinical trial conducted by the University of Washington involved 30 frontline clinicians experiencing moderate to severe depression. Participants received either a 25 mg dose of psilocybin or a placebo, alongside psychotherapy sessions. The psilocybin group exhibited a significant reduction in depression symptoms compared to the placebo group, with improvements sustained over six months. This research suggests that psilocybin, combined with psychotherapy, could be a viable treatment for depression in healthcare workers resulting from pandemic-related stress. However, experts emphasize the necessity for larger-scale studies to confirm these findings and to assess ...