What is MediCabilis?

Further information on BOD’s pharmaceutical grade Medicinal Cannabis

What is MediCabilis™?

MediCabilis™ is a type of medicinal cannabis that can be used for a number of conditions.

What is medicinal cannabis?

Medicinal cannabis is cannabis in any form (e.g. oils, capsules, flower, spray) that is prescribed by a doctor for specific medical purposes.

How is medicinal cannabis different to recreational cannabis?

Medicinal cannabis is different to recreational cannabis because the bioactive compound profile of medicinal cannabis is known and is manufactured under strict conditions to comply with Good Manufacturing Practice, ensuring consistency in product quality and therapeutic effect.

What are the active ingredients of MediCabilis™?

The cannabis plant contains more than 400 plant constituents with approximately 100 that are specific to the cannabis plant and referred to as cannabinoids and primarily responsible for therapeutic activity. Cannabidiol (CBD) is the predominate cannabinoid in MediCabilis™. MediCabilis™ 5% CBD ECs315 also contains terpenes, which are the naturally occurring compounds found in many plants that give plants their flavor, odour and protect them against microbes. Terpenes also have therapeutic properties.

Does MediCabilis™ have intoxicating effects?

The active ingredient responsible for the intoxicating effects of some cannabis is tetrahydrocannabinol (THC). THC is not present in the MediCabilis™ 25 CBD Isolate or the MediCabilis™ 100 CBD Isolate, while the MediCabilis™ 5% CBD ECs315 contains less than 0.2%, so these products when taken appropriately should not induce an intoxicating effect.

MediCabilis therapeutic indications:

MediCabilis™ does not have approved indications. There are no restrictions imposed by the TGA on the indication/s for which a health practitioner may apply to access an unapproved medicinal cannabis product for their patient
Use is at the discretion of the prescribing practitioner based on the individual needs of the patient and on the evidence for CBD medicines. A number of conditions for the use of cannabis extracts have been documented, and are listed for consideration below.

These include (but not limited to):

Chemotherapy-Induced nausea and vomiting (CINV)
• Management of epileptic seizures and conditions
• Inflammatory bowel disease
• Inflammation related conditions
• Anxiety
• Multiple sclerosis
• Pain conditions included neuropathic pain, fibromyalgia, rheumatoid arthritis, and mixed chronic pain

What are the side-effects of MediCabilis™?

The most commonly experienced adverse effects are:

  • drowsiness (8% or 8 in 100)
  • nausea (8% or 8 in 100)
  • sedation (8% or 8 in 100)
  • altered sensory perception (8% or 8 in 100)

The amount of THC is less than 0.2%, hence psychiatric effects are not expected. However, should adverse effects occur the medicine should be adjusted by the prescribing practitioners. Patients should promptly report any exacerbation of psychiatric symptoms such as depression , disorientation, feeling over-excited or losing touch with reality, have difficulty speaking, eating (more or less than usual), or hallucinations.

MediCabilis™ Quality Control

The TGA has established quality standards for medicinal cannabis products that companies who import, manufacture and supply medicinal cannabis products in Australia are required to meet. MediCabilis™ products are frequently tested by independent third-party vendors for quality.

MediCabilis safety and tolerability

MediCabilis™ 5% CBD has been shown to be well tolerated. A Phase 1 clinical trial in healthy volunteers demonstrated MediCabilis™ 5% CBD:

  • Had no serious adverse events
  • Adverse events that did occur were mild and as expected
  • There were no clinical abnormalities reported in vital signs, ECG, physical findings or safety laboratory tests

CBD is devoid of the psychotropic effects that are observed with THC, it is well-tolerated and has been established as generally safe with few serious adverse effects.1-3 Furthermore, a report by the World Health Organization also found no adverse health outcomes, no public health risks or abuse potential WHO report.4

Driving regulations

In Australia, it’s an offence to drive with THC in the blood stream, even if it’s prescribed.

MediCabilis™ Isolates (25 CBD Isolate or 100 CBD Isolate) are suitable for driving. The MediCabilis™ 5% CBD ECs315 contains a very small amount of THC (<0.02%; NMT 2mg/mL) which may be detectable in the bloodstream and other body fluids.

References

  1. Pauli C, et al. Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. Front Pharmacol. 2020; 11: 63.
  2. Chesney E, et al. Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. Neuropsychopharmacology. 2020.
  3. Dos Santos R, et al. Serious adverse effects of cannabidiol (CBD): a review of randomized controlled trials. Expert Opin Drug Metab Toxicol, 2020.
  4. World Health Organisation, Cannabidiol Critical Review Report. Expert Committee on Drug Dependence. 4-7 June 2018 https://www.who.int/medicines/access/controlled-substances/CannabidiolCriticalReview.pdf