Cannabis; psychedelics; psilocybin: three therapeutic substances that - until just a few years ago - were left languishing in the ‘recreational’ and ‘illegal’ circles of the pharmaceutical Venn diagram. Although there is evidence that psychedelic compounds have been used in traditional medical practice for millennia, the social taboos and legal architecture around the consumption of these substances has blocked their widespread application in recent medical practice.
As positive evidence mounts and the regulatory landscape evolves, new opportunities are emerging for patients to benefit from treatment with alternative medicines. This new era has been ushered in by hard-won legislative change. In 2018 it became legal for patients to be prescribed cannabis-based medicines in cases of ‘exceptional clinical need’, and in 2020 the UK government granted researchers a licence to use DMT – a psychedelic compound found in several plants - to investigate its efficacy in treating depression.
Even though it is now legal for eligible patients to access previously banned drugs, securing a prescription and treatment can be an expensive and challenging ordeal. This is because of a lack of research into the treatments is preventing further legislative reform, and because of the complexities and regulations which make the dispensing and delivery process fraught with difficulty. This is putting patients at considerable inconvenience, expense, and in extreme cases, risk of prosecution should they seek a black-market supply.
In a bid to bridge the gap, several startups are stepping up to these challenges: pioneering research, building the digital infrastructure, and together supporting thousands of patients to legally access life-changing therapeutics. Here are four of today’s game-changers.
Long before new treatments can be safely rolled out to patients, extensive research and clinical trials must be carried out. Securing the funding and approvals for regular life sciences R&D can be hard enough, but it takes a whole extra level of perseverance to innovate in the constantly changing domain of controlled substances.
One biotech company doing just that is Awakn Life Sciences. Their goal is to bring new, impactful addiction treatment to the one billion plus people worldwide who are affected by substance and behavioural addiction. Existing treatments typically result in low recovery rates, however, there is evidence that psychedelic drugs can disrupt the brain circuitry driving addiction and enable individuals to engage with therapy and recovery in a unique way. Awakn’s team has successfully conducted the world’s only clinical trials of ketamine and MDMA in a therapeutic setting as treatments for alcohol use disorder, and they are currently conducting trials for gambling addiction, binge eating disorder, internet gaming disorder and compulsive sexual behaviour. Evidence from these trials will play a central role in any future attempts to legalise the use of psychedelics for the mass patient market.
Also blazing a trail in the research landscape is Beckley Psytech. This group of clinicians, psychotherapists, product designers, data scientists and software engineers are developing a pipeline of psychedelic compounds into licensed pharmaceutical medicines, to help people suffering from neuropsychiatric disorders (including schizophrenia, bipolar disorder, major depressive disorder and attention deficit hyperactivity disorder). In May 2023, the first patient with treatment resistant depression was treated in Beckley’s trial of their novel synthetic formulation of a psychedelic compound. The results of this trial, expected later in the year, will inform the future clinical development of synthetic psychedelic drugs and could transform outcomes for patients.
Securing a prescription for a recently legalised medication can be extremely difficult, as doctors may be reluctant to prescribe owing to a lack of experience or confusion over the criteria for prescriptions. Once this hurdle has been cleared, having the prescription filled can present further difficulty due to tightly controlled supply chains. Increasingly, patients have been turning to digital healthcare VIMPROs offering a seamless journey from initial consultation to medication delivery.
In the US, Mindbloom are the leading private providers of ketamine therapy via telemedicine. Their unique service is designed for the treatment of anxiety and depression, and packages together an assessment, home-delivery of ketamine medication, and live support from a trained guide. This combined offering works to remove the barriers of waiting for appointments and travelling to a specialist, whilst the cost is significantly lower and the outcomes more successful than traditional anxiety and depression treatment programmes in the US.
Here in the UK, Leva Clinic has been championing the interests of chronic pain patients since medical cannabis’ partial legalisation in 2018. Because cannabis is classed as an unlicensed medicine, it can only be prescribed by specialist doctors. In addition, distributors must follow rigid processes for signed-for delivery and medication disposal. This places barriers in the path of home-delivery cannabis telemedicine providers, which in turn causes problems for chronic pain patients - who often struggle with mobility and so cannot easily travel to appointments and pharmacies. However, working in partnership with Phlo Technologies, Leva Clinic has built a compliant and robust set of procedures to dispense and deliver medical cannabis treatments all over the country. Leva Clinic’s patients can now use the digital platform to book a consultation with a chronic pain specialist, to receive their cannabis prescriptions, and to order and pay for their medications to be delivered.
Mindbloom and Leva Clinic both serve as proof that digital providers, in partnership with digital pharmacy infrastructure specialists, can effectively navigate the logistics of alternative medicine licensing, ordering, safe storage and expiry management processes. With careful planning and the right systems in place, these providers can also offer a secure prescription and patient audit trail – as required by law - and can ensure that all prescription and delivery processes are fully compliant.
As R&D in the cannabis and psychedelics sector gathers momentum, regulators and healthcare organisations are continuing to grapple with the implications. And although we still do not know when exactly these treatments will become established UK medical practice, the trajectory towards legalisation is underway. Now is the time to create the systems and infrastructures necessary for the success of new therapeutic practices. The sooner providers and regulators establish secure and seamless patient access pathways, the sooner patients will reap the physical and mental benefits.
If you are a digital health provider championing improved access to cannabis, ketamine or psychedelic medication, speak to a member of the Phlo team about how we can work together to deliver life-changing treatment options to your patients. Get in touch.