Cannabis Based Medicine Life Science and Healthcare Treatment
Life Science
What Medical Cannabis isn’t 3
What Medical Cannabis isn’t Medical cannabis is NOT about getting high, it is about the therapeutic benefits of the 2 most researched cannabinoids, CBD and THC 4
What Medical Cannabis isn’t She takes FDA approved CBD (still awaiting a licence in EU) This is Karen, she has epilepsy 5
Cannabidiol (CBD) CBD is non- psychoactive (does not alter brain function) CBD* is already used for: • Pain Relief and Inflammation • Epilepsy • Anxiety and Depression • Nausea and vomiting from chemotherapy *(usually in oil format) 6
Cannabidiol (CBD) e on) CBD is being researched for : • Drug withdrawal (from nicotine to opioids) • Diabetes • Anti-tumour effects • Improving quality of life for those with Parkinson’s or Alzheimer’s 7
Side Effects of CBD • Side effects of CBD based pharmaceuticals are substantially more mild than other Epileptic pharmaceuticals 8
Cannabidiol (CBD) • CBD is non-psychoactive cannabinoid i.e. it does not alter brain function • Studies show it provides a safer more natural treatment than many other medications used to otherwise treat epilepsy such as steroids • Research has found no significant side effects on the central nervous system, the cardiovascular system or mood, even among people who used high dosages. • The most common side effect is tiredness. 9
Methods of Administration & Properties of CBD NOT LIKE TOBACCO Methods of Administration NOT LIKE It is an oral solution, is tolerated • Oral solution (Epidolex) well and has a good safety profile. TOBACCO Properties of CBD “The evidence from well controlled NOT LIKE • human experimental research Non psychoactive OPIOIDS indicates that CBD is not • Non addictive associated with abuse potential” World Health Organisation 10
What Medical Cannabis looks like He has a choice of two medications: Dronabinol capsules or oil, structurally identical to THC Nabilone capsules, a synthetic cannabinoid that mimics THC This is John, he has uncontrolled nausea and vomiting from chemotherapy 11
What is Tetrahydrocannabinol (THC)? THC is the active component of THC is already used for : cannabis and results in temporary • Loss of appetite in people with AIDS changes in perception, mood • To treat nausea and vomiting caused consciousness and behaviour by chemotherapy • Treatment of spasticity in patients with Multiple Sclerosis • Pain control • PTSD 12 • • • • • • • • • •
What is Tetrahydrocannabinol (THC)? THC is being researched for : • Chronic and neuropathic pain • Protecting brain cells and brain growth (can treat/slow down Alzheimers) • Treating antibiotic resistant pathogens such as MRSA • Asthma and COPD 13
Side Effects of THC • Side effects of THC based pharmaceuticals are substantially more mild than other nausea suppressing or anti-spasticity pharmaceuticals 14
Methods of Administration & Properties of THC NOT LIKE TOBACCO Methods of Administration NOT LIKE They are tablets, not smoked • Tablet TOBACCO • Prescription only given when all Properties of THC NOT LIKE other avenues exhausted • Neuroprotectant OPIOIDS • • Addictive potential is Natural pain relief considerably lower than opioids. • Effective for PTSD • Psychoactive 15
What Medical Cannabis looks like She takes Sativex, that contains both CBD and THC in a 1:1 ratio, to reduce spasticity caused by MS which affects her muscles Nabilone capsules, a synthetic cannabinoid that mimics THC This is Kathleen, she has MS 16
What Medical Cannabis looks like Studies have shown that almost 75% of patients reported a pain reduction after using Sativex 17
Entourage Effect Products have been Evidence has shown that created containing both CBD modulates the effect CBD and THC of THC therefore limiting the risks of THC 18
Side Effects of CBD and THC Combined • Side effects of CBD and THC Combined based pharmaceuticals are substantially more mild than other epileptic pharmaceuticals 19
Methods of Administration & Properties of CBD & THC Methods of Administration NOT LIKE Sub-lingual, • Sub-lingual not smoked TOBACCO Properties of CBD Properties of CBD and THC combined • The benefits of CBD seem to wear off after a few months unless a little THC is added • Combining CBD and THC reduces the psychoactive side effects of the NOT LIKE latter cannabinoid OPIOIDS • CBD can also lessen the sedative and appetite-inducing effects of THC • Combining CBD and THC can improve the pain-fighting properties of both 20
Process of approval Approval of medications containing CBD or THC are subject to the same process as any other drug Pre- Phase 2 Phase 3 Phase 1 Pre-clinical Research registration Entre in Marketing authorisation Launch to humans application • Understand disease • Test candidate drugs • Test safety healthy • Test efficacy in • Confirm efficacy in • FDA/EMEA reviews Stage mechanisms in laboratory and volunteers (20-200 larged desease larger patient 100.000 pages objectives populations (300 – animals for toxicity people) (in 200-300 people) application and • Identity targets and side-effects and 3000 people) decides whether • Determine compounds against therapeutics value to great approval • Monitor side effects them appropriate dose 0.1% 1% 5% 10% 50% 75% Probability of reaching launch 3-5 1-2 1-2 1-2 2-3 1-2 Duration (years) 21
US Pharmaceutical Warnings FDA Black Box Warnings are added to drug literature if: • If an adverse event is so serious (death or a permanently disabling reaction) in proportion to the potential benefit from the drug that it is essential to consider when There are no FDA black weighing the risks and benefits of the drug box warnings on any • If a serious adverse reaction can be prevented, reduced of the cannabis derived in frequency, or made less severe by following certain guidelines, such as patient selection, careful monitoring, products, synthetic or taking into account other medication that the person or natural might be taking • If there are mandatory restrictions for prescribing the drug. Some medication may only be administered in certain settings (supervised or inpatient) or may require the doctor to complete extra training in order to prescribe 22
EU Pharmaceutical Warnings There are no • The EU does not have an equivalent Black black triangles Box Warning because all of the information around risk and adverse reactions is on any of written within the Summary of Product the cannabis Characteristics (SmPC) and Patient derived Information Leaflet. products, synthetic • In the EU there is scheme for the additional or natural monitoring of medicines, known as the black triangle. It shows that the medicine is being closely monitored by European regulatory authorities and is usually applied to new medicines. 23
Cannabis Based Medicine Life Science insurance implications
Life Science - Liability exposures Clinical trial Product Professional Liability Liability Indemnity A participant to a clinical Product - after being Errors and omissions in trial suffers injury as a approved by the authorities - providing service to result of participation to does not provide the safety pharmaceutical companies the trial one can expect. Product resulting in property damage, include package, container, bodily injury or pure financial label and instructions. loss 25
Life Science - appetite Appetite for • GMP manufactured • Prescribed by a healthcare professional • Approved by FDA or EMA for specific indications • Clinical Trials No appetite for • Stand alone cultivators • Hemp products • Recreational use • Nutraceuticals 26
Healthcare Treatment
What Medical Cannabis products can be prescribed? Nabilone Sativex Indicated for nausea and Indicated for symptom improvement vomiting caused by chemotherapy, in adult patients with moderate to if patient is unresponsive to severe spasticity due to Multiple conventional anti-sickness Sclerosis who have not responded to medication other anti-spasticity medication Epidiolex Dronabinol Indicated for Lennox-Gastaut Indicated to treat loss of appetite Syndrome or Dravet Syndrome in people with AIDS and to treat (severe epilepsy) in patients 2 years severe nausea and vomiting caused of age and older. (FDA approved, by chemotherapy in patients with awaiting EU approval) inadequate response to conventional anti-sickness medication. 28
Types of cannabis based medicinal products Licensed Medicines 1 (Prescriptions) Non ‐ Licensed Medicines 2 ( Prescriptions ) Non Licensed Non Prescribed 3 ( Nutraceuticals ) 29
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