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DEA grants approval for the manufacture of psychedelic compounds

Compounds that have been approved include psilocybin, MDMA, 5-MeO DMT and DMT.

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DEA grants approval for the manufacture of psychedelic compounds

Drug developer Benuvia has received approval from the DEA to manufacture psychedelic Active Pharmaceutical Ingredients (APIs).

Benuvia will manufacture the APIs in its 83,000 square foot manufacturing facility that is permitted by the US DEA for Schedule I to III Controlled Substances. The facility is FDA registered and a cGMP facility.

Primarily specialising in cannabinoids, with the approval, Benuvia has begun focusing on four primary psychedelic ingredients: psilocybin, 5-MeO DMT, DMT, and MDMA.

Benuvia CCO, Joe Shupp, commented: “We are excited to announce our approval by the DEA to manufacture Psilocybin, MDMA and DMT for emerging providers of psychedelic-based drugs focused on neural and mental illness indications.

See also  Groundbreaking psilocybin study results show promise for depression

“As pharmaceutical companies become more aware of the positive effects of cannabinoids and psychedelic compounds for therapeutic use, the demand for APIs is expected to grow. Our diversified portfolio of APIs and entry into the development of novel psychedelic compounds aims to strengthen Benuvia’s position as a drug developer and provider of APIs focused on cannabinoids and psychedelics.”

With this approval, Benuvia is now able to offer the APIs to drug developers and research organisations under the CSA, and it will also enable the company to advance its life cycle management services to drug developers for their psychedelic development programmes. 

The company has stated that it intends to develop novel intellectual property formulations of these psychedelic compounds, and will provide full toxicology, chemistry, manufacturing and controls, or CMC, and full data analysis. 

See also  Canada's amendment allowing patients access to psychedelics welcomed

Through its partners, Benuvia also intends to manage all research and development, manufacturing, analytical methods, intellectual property capture, placebo manufacture, randomisation and assistance with clinical trials, which will enable it to create custom technologies that allow rapid and cost-effective scale up of commercial operations for production in anticipation of research success.

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Partnership aims to optimise patient outcomes in psychedelic clinical trials

Beckley Psytech and Ksana Health will be building on digital strategy to deliver optimised patient outcomes.

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Partnership aims to optimise patient outcomes in psychedelic clinical trials

The partnership is aiming to collect and analyse digital biomarkers to identify signs of response and relapse in Beckley’s upcoming 5-MeO-DMT Phase 2 clinical trials.

Beckley Psytech and Ksana Health’s partnership will support the collection and analysis of digital behavioural data in the  clinical trials. 

Through the partnership, Beckley Psytech aims to track novel, predictive digital biomarkers to follow patient progress in the trials, which will be evaluating the use of 5-MeO-DMT in combination with psychotherapy in the treatment of treatment resistant depression (TRD).

See also  Beckley Psytech collaboration to develop next-gen psychedelic medicines

CEO of Beckley Psytech, Cosmo Feilding Mellen, said: “This partnership with Ksana Health further supports our strategy to develop an integrated psychedelic treatment model, ensuring that patients are continuously supported throughout their treatment journey. 

“We look forward to working with Ksana Health and exploring how their state-of-the-art digital technology can help support patient safety and response in our upcoming Phase 2 clinical trials.”

Using Ksana Health’s Effortless Assessment Research System (EARS), an end-to-end solution for mobile sensing, Beckley will collect passive mobile device metadata from clinical trial participants’ smartphones, in order to identify individual signals of potential response and relapse. 

Co-founder and CEO of Ksana Health, Dr Nick Allen, commented: “Psychedelic treatments are offering exciting new approaches to recovery from mental disorders. However, we need rigorous clinical trials to ensure that this promise is realised. 

See also  Beckley Psytech doses first patients in novel 5-MeO-DMT study

“We are therefore very excited to partner with Beckley Psytech to help them build out their digital strategy. By using our continuous behavioural health measurement tools, we can help Beckley Psytech to understand each patient’s journey more deeply, which will ultimately allow for more effective and personalised treatments.”

The company has stated that this latest partnership further strengthens its digital strategy to develop personalised, end-to-end treatment programmes for patients in areas of significant unmet medical need.

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Patent application filed for ketamine as behavioural addiction treatment

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Patent application filed for ketamine as behavioural addiction treatment

Awakn Life Sciences has filed a Patent Cooperation Treaty (PCT) application for the treatment of behavioural addictions with ketamine and ketamine-assisted psychotherapy. 

The successful completion of Awakn’s behavioural addictions study was announced last week and the data provided from the study was used in the patent filing. 

The pilot study investigated ketamine as a potential new treatment approach for Gambling Disorder, Internet Gaming Disorder, Compulsive Sexual Behavior Disorder and Binge Eating Disorder.

The PCT covers all behavioural addictions or any recognised disorder or condition with similar compulsive symptoms to those in the study. If granted, the patent claims would give Awakn exclusive rights to use ketamine and ketamine-assisted therapy for the treatment of behavioural addictions.

Awakn CEO, Anthony Tennyson, commented: “Today’s news demonstrates our focus on researching, developing and commercialising therapeutics to treat addiction.  

“A core part of our efforts is to continually strengthen our IP portfolio as we work to bring effective therapies to chronic addiction sufferers in desperate need. 

“To be forging a path to find an effective treatment for such a vast unmet medical need is critical and an effort we are very proud to be a part of.”

With no effective pharmacological treatments available globally at present for behavioural addictions, the study results and the patent filing position Awakn at the forefront of the industry at a time when rates of behavioural addictions are increasing at an alarming pace and sufferers have few treatment options which deliver poor outcomes.

The promising results from the pilot study showed a reduction of symptoms for some participants, with some participants no longer meeting the criteria for a diagnosis. Some individuals also showed a reduction of the symptoms of a comorbid psychiatric condition, such as depression or anxiety. The treatment was also well tolerated with no safety concerns.

Gambling Disorder, Internet Gaming Disorder, and Binge Eating Order are all recognised in the DSM-5, which is a diagnostic tool that serves as the principal authority for psychiatric diagnoses in the US, and affect up to 450 million, 235 million and 100 million people respectively. While Compulsive Sexual Behavior Disorder, which is included in the ICD-11, affects up to 350 million[4] people. 

The ICD-11 was developed by the World Health Organization (WHO) and is the global standard for recording health information and causes of death. Current standard of care for all of these conditions is poor.

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Top UK and European academics join Clerkenwell Health advisory board

Renowned academics in the field of psychedelics from leading European universities will be joining clinical research organisation Clerkenwell Health.

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Top UK and European academics join Clerkenwell Health advisory board

Clerkenwell Health is expanding its pan-European advisory board with the addition of Dr David Erritzoe, Dr Dea Siggaard Stenbæk, Dr Kim Kuypers and Dr James Stone from Danish, Dutch and British universities.

With psychedelic research flourishing in Europe, Clerkenwell Health says it is building connections between commercial research organisations and academic institutions. 

The expansion of its advisory board will give the company access to knowledge and networks from some of the most prestigious European universities – working to fulfil the company’s mission to create a more vibrant psychedelic clinical trial ecosystem and foster wider sharing of best practices across Europe.

Discover how Clerkenwell Health is developing a gold standard for psychedelic care

Chaired by Dr Henry Fisher, the Clerkenwell Health CSO, the board will focus on clinical research and therapy, with its new members bringing expertise in areas of psychotherapy, psychopharmacology, mental health, experimental medicine and psychedelics.

Speaking to Psychedelic Health, CEO of Clerkenwell Health, Tom McDonald, said: “The UK is an attractive location to undertake psychedelic drug development as the government are opening up innovation pathways and championing clinical research.

“We are excited to be joined in our work exploring psychedelics-assisted therapy here in the UK with leading experts from prestigious European universities. Their involvement ensures we have a variety of expert opinions to shape innovative trial designs whilst preparing a platform for European expansion in the coming years.”

See also  Clerkenwell Health is launching a free UK psychedelic therapist training programme

With an aim to support the commercial research ecosystem in the UK and Europe, the new board additions place Clerkenwell Health as an ideal partner to support drug developers wishing to conduct trials in European countries.

CSO of Clerkenwell Health, Dr Henry Fisher, stated: “I am delighted to be able to bring together such high calibre advisors into the Clerkenwell Health scientific advisory board. These researchers are leaders in their respective fields in Europe and are shaping the direction of clinical and fundamental research with psychedelics. 

“This gives us access to the knowledge and network built in some of the most prestigious universities from Copenhagen to Maastricht and London, and it is a privilege to be able to consult with these figures on our own research.”

Meet the advisory board

Dr David Erritzoe is clinical director and deputy head of the Centre for Psychedelic Research at Imperial College London.

Erritzoe is currently investigating brain mechanisms and therapeutic potential of MDMA, ketamine and classic psychedelics, and is clinical senior lecturer in general psychiatry in Centres for Neuropsychopharmacology and Psychedelic Research at Imperial, as well as consultant psychiatrist at St Charles Hospital, CNWL Mental Health NHS Foundation Trust. Erritzoe also heads a NHS-based research clinic at St Charles Hospital, the CIPPRes Clinic.

Dr Dea Siggaard Stenbæk is an associate professor at University of Copenhagen and Copenhagen University Hospital. 

Stenbæk’s research mainly focuses on neuropsychopharmacological effects of the 5-HT2A receptor agonist psilocybin. She collaborates with the Centre for Psychedelic Research at Imperial College London and is currently an honorary clinical research fellow in this group. As the clinical lead, she works on a study of psilocybin as a treatment for obsessive compulsive disorder.

Dr Kim Kuypers is an associate professor at Maastricht University. Her PhD focused on memory and risk-taking during MDMA intoxication. 

Kuypers’ main goal is to understand the neurobiology underlying flexible cognition, empathy and wellbeing. To accomplish this she uses a psychopharmacological model, studying the (sub)acute and longer-lasting effects of psychedelics on these behaviours and their underlying biology.

Dr James Stone worked as a clinical senior lecturer at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, with a focus on experimental medicine and clinical trials. 

During his time there, Stone set up the ketamine clinic at the Maudsley Hospital for patients with treatment-resistant depression. He also worked at Imperial College London as a senior lecturer, working as co-director of the intercalated BSc in neuroscience as well as continuing research into the role of glutamatergic abnormalities in psychosis.

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