Latest news with #GerhardGründer
Forbes
5 days ago
- Health
- Forbes
Germany Approves EU's First Psilocybin Access Program
Germany has become the first country in the European Union to allow access to a psychedelic for a limited number of patients under strict conditions. The country's drug regulator, the Federal Institute for Drugs and Medical Devices (BfArM), has given the green light for two medical facilities to offer psilocybin to adults with treatment-resistant depression. Depression is one of the most common mental illnesses in Germany, affecting around 5.3 million people. Up to a third of cases are considered to be "treatment-resistant', meaning the individual hasn't responded adequately to conventional treatments. In recent years, scientific research has pointed to psilocybin—the active ingredient found in certain types of mushrooms—as a promising treatment for this type of depression, along with other psychiatric conditions. While no drugs containing psilocybin are currently authorized for use in Germany or the EU, the Expanded Access Program enables the use of as-yet-unapproved drugs in patients suffering from serious or life-threatening illnesses. Under the direction of Professor Gerhard Gründer, head of the department of molecular neuroimaging at the Central Institute of Mental Health (CIMH), individual patients in Mannheim and Berlin will be able to receive the drug in justified exceptional cases. Prof Gründer, who successfully made the application, said in a statement: 'In selected individual cases, the therapeutic use of psilocybin as part of a Compassionate Use Program can be a medically and ethically justifiable option, provided it is carried out under strictly controlled conditions and with careful medical supervision.' Very few such programs for psilocybin have been established worldwide, with Germany's model expected to be similar to those operating in Switzerland and Canada. While Switzerland is a European neighbour of Germany, it is not a member of the EU, and regulations allowing the legal use of psilocybin, MDMA, and LSD in certain cases were introduced in 2014. Demand Expected To Exceed Supply A botanical psilocybin drug candidate known as PEX010, will be provided by Canadian company Filament Health, which also supplies the vast majority of psilocybin prescribed under Canada's Special Access Program. The drug will be administered to patients at the CIMH in Mannheim and the OVID Clinic in Berlin, on an inpatient basis only, and in combination with psychotherapy, to help patients 'release rigid thought patterns, promote new insights, perspectives, and behaviors, and improve depressive symptoms'. Announcing the news in a press release, Benjamin Lightburn, co-founder and chief executive officer at Filament Health, commented: 'The approval of PEX010 for this milestone moment in European psilocybin access reinforces Filament's position as the world's leading supplier of GMP-quality psychedelic drug candidates. 'We're incredibly proud that our drug product will be the first psilocybin to be administered under compassionate use in the EU. It's a validation of Filament's ongoing efforts to make safe, standardized psychedelic medicines available to those who need them most.' However, while an 'enormously important step', compassionate access programs are not thought to be a suitable substitute for the wider regulatory approval, and demand is expected to 'far exceed supply'. 'Experience from Switzerland shows that demand far exceeds the available supply. This is also likely to be the case in Germany,' continues Gründer 'A Compassionate Use Program cannot replace approval. We must therefore continue to work on bringing psychedelics such as psilocybin into standard care for the treatment of mental illness.' Legitimizing Psychedelic Medicine Elsewhere in Europe, the Czech Republic has also taken steps to legalize the therapeutic use of psilocybin. On 30th May, the lower house of the country's parliament passed an amendment to allow the use of psilocybin in psychiatric hospitals and clinics from 2026. If passed in the senate, this would make the Czech Republic the first EU country to legally regulate the treatment for medical use. Meanwhile, the UK has recently seen a potentially significant policy shift, with the government backing a proposal put forward by the Advisory Council on the Misuse of Drugs to remove the requirement for research licences when studying Schedule 1 drugs such as psilocybin and MDMA. Josh Hardman, founder and editor of media and consultancy firm, Psychedelic Alpha, said over email that while Germany's program may be limited in scope, it could be significant for 'legitimizing' psychedelic medicine and influencing wider regulatory change across Europe. 'While the program might only reach up to around 50 patients in its first year, the significance of the German regulator's decision should not be lost on people,' says Hardman. 'The country now joins Switzerland in allowing certain European patients to access psilocybin when they have exhausted other options. What's more, the imprimatur of Swiss engineering and German efficiency and process focus could add to psychedelic medicine's legitimacy both in Europe and beyond.' He adds: 'I have spoken with the architects of this compassionate use program and am encouraged to hear that they are keen to collect and share data from the project. Such real-world data and learnings would be very useful for the field. If those experiences are broadly positive, other EU member states might consider joining.'
Euronews
31-07-2025
- Health
- Euronews
Germany to allow some depressed patients to try psychedelics
Germany's medicine regulator will allow certain patients with treatment-resistant depression to try psilocybin therapy, a major shift as psychedelics inch closer to mainstream medicine. It is the first time in the European Union that psilocybin – the hallucinogenic compound in magic mushrooms – will be made available through a compassionate use scheme, in which patients with serious or life-threatening illnesses can get access to drugs that have not yet been approved. In Germany, psilocybin will only be prescribed in 'justified exceptional cases,' according to the Central Institute of Mental Health (CIMH), which asked regulators to greenlight the programme. 'This is an enormously important step that expands our scope for action,' Dr Gerhard Gründer, head of CIMH's molecular neuroimaging department, said in a statement. In some cases, psilocybin therapy 'can be a medically and ethically justifiable option, provided it is carried out under strictly controlled conditions and with careful medical supervision,' Gründer added. Depression is a common mental health problem, but approximately 20 per cent to 30 per cent of people with depression do not respond well to standard treatments, CIMH said. Studies have shown that psilocybin could be a promising alternative for these patients. The drug is thought to foster connections between different regions of the brain, helping people let go of excessive self-focus and rumination, according to scientists from the United Kingdom and United States. But sceptics have warned that studies on psychedelic drugs can be hard to replicate. Growing interest in psychedelics The decision from Germany's Federal Institute for Drugs and Medical Devices (BfArM) reflects growing interest in psychedelic therapies, including psilocybin and MDMA, as a treatment for mental health issues such as depression, anxiety, addiction, and post-traumatic stress disorder (PTSD). Earlier this month, the Czech Republic legalised the medical use of psilocybin for conditions such as depression. Meanwhile, the first EU-funded trial on psychedelic medicines launched last year to test whether psilocybin can alleviate anxiety and depression among patients with progressive diseases such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). Other clinical trials are also underway in Europe, including in Germany, though full approval for psilocybin is not expected in Germany for several years. In the meantime, the Psychedelic Access And Research European Alliance (PAREA), a nonprofit advocacy group, said compassionate use programmes can complement clinical trials by offering real-world data on these treatments and ensuring they are available for 'patients who cannot wait' for full approval. CIMH expects that many patients will be interested in Germany's limited access scheme. 'Experience from Switzerland shows that demand far exceeds the available supply,' Gründer said. 'We must therefore continue to work on bringing psychedelics such as psilocybin into standard care for the treatment of mental illness,' he added.
Cision Canada
31-07-2025
- Health
- Cision Canada
FILAMENT HEALTH ANNOUNCES FIRST-EVER COMPASSIONATE USE APPROVAL FOR PSILOCYBIN IN THE EUROPEAN UNION
Filament's botanical psilocybin drug candidate PEX010 to be administered in Germany for treatment-resistant depression VANCOUVER, BC, /CNW/ - Filament Health Corp. (OTC:FLHLF) (" Filament" or the " Company"), a clinical‐stage natural psychedelic drug development company, today announced the first-ever approval for compassionate use of psilocybin in the European Union (EU). The Company's botanical psilocybin drug candidate, PEX010, has been authorized for administration to a patient suffering from treatment-resistant depression (TRD) in Germany. The approval was granted under Germany's compassionate use framework and marks the first time psilocybin will be prescribed outside of a clinical trial in the EU. The treatment will be conducted by Dr. Gerhard Gründer at the Central Institute of Mental Health, Department of Molecular Neuroimaging. "This is a landmark moment for the field of psychedelic medicine in the European Union. Treatment-resistant depression affects up to 30% of individuals diagnosed with major depressive disorder and remains one of the most difficult psychiatric conditions to treat. Psilocybin has demonstrated significant promise as a novel therapeutic option, and this approval marks an important step toward expanding access for those in urgent need," said Dr. Gerhard Gründer. "I am honoured to play a role in expanding European access to psilocybin and grateful to the team at Filament Health for their support." "The approval of PEX010 for this milestone moment in European psilocybin access reinforces Filament's position as the world's leading supplier of GMP-quality psychedelic drug candidates," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "We're incredibly proud that our drug product will be the first psilocybin to be administered under compassionate use in the EU. It's a validation of Filament's ongoing efforts to make safe, standardized psychedelic medicines available to those who need them most." ABOUT FILAMENT HEALTH (OTC:FLHLF) Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates. Learn more at and on X, Instagram, and LinkedIn. FORWARD LOOKING INFORMATION Certain statements and information contained in this press release and the documents referred to herein may constitute "forward‐looking statements" and "forward‐looking information," respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, "expect", "anticipate", "continue", "estimate", "may", "will", "should", "believe", "intends", "forecast", "plans", "guidance" and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements. Forward‐looking statements regarding the Company are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws.
