NanoCelle® Buccal Spray from Cannabis Oil Extract
NanoCelle® THC/CBD (1:1) - Late Stage Drug.
NanoCelle® Buccal Spray from Hemp Oil Extract
NanoCelle® CBD - Drug Under Investigation
This page is intended to communicate the innovation of NanoCelle® and provide general information on medicinal cannabis and its use for medical reasons when conventional therapies have failed, the endocannabinoid system and its interaction with cannabinoids, and how to access unregistered products.
Medlab has created a cannabis-based medication, NanaBis™ and NanoCBD™, that is currently under investigation. It is an unregistered therapeutic good that is not listed on the Australian Register of Therapeutic Goods (ARTG) and is only available via Special Access Scheme (SAS-A or SAS-B), Authorised Prescriber (AP) scheme, or clinical trials. If you’re wondering whether this cannabis-based medicine might be right for your condition, your first step is to have a conversation with your doctor or book an appointment for a screening consultation to evaluate if you are an eligible patient.
Improving THC and CBD absorption with NanoCelle®
THC and CBD are lipophilic molecules that undergo erratic oral absorption and extensive first-pass metabolism. Both THC and CBD have poor oral bioavailability, estimated to be as low as 6%. Poor absorption also leads to slow onset of action.
To address this issue, Medlab utilises NanoCelle®, a proprietary delivery technology that is effective, safe, and convenient, administered as an oro-buccal spray inside the cheek.
Insoluble molecules (such as cannabinoids) are contained in water-soluble nanoparticles (5-95nm) designed to pass the 40-50 cell layer thick buccal mucosa. This route provides rapid access to the bloodstream via the facial lymphatic system, bypassing first-pass gut metabolism.
Accessing an unregistered cannabis-based product
This video provides information about how the TGA provides safe and legal access to medicinal cannabis products in appropriate circumstances. TGA has useful resources to help you navigate the special access scheme for the access of unregistered drugs that are currently under investigation. Individual consumers cannot apply to the TGA to obtain access to unapproved medicinal cannabis products. Access can only be arranged through an Australian registered health practitioner. Approval or authorisation is granted on a case-by-case basis.
This work is copyrighted and belongs to TGA
Frequently asked questions
Cannabis has been a medicinal plant of unparalleled versatility for thousands of years. The first historical evidence has been traced to ancient China around 5000 years ago, where extracts were used to relieve cramps and pain.
For some people suffering chronic or terminal illnesses, conventional medicines may not work or might not be as effective as medicinal cannabis. In other cases, traditional medications may work in some patients but cause severe side effects that medicinal cannabis can help alleviate or eliminate. Poor management of these chronic conditions can adversely impact the quality of life, interfering with physical and mental health, family, social life, and work.
Medical cannabis prescribed by a doctor can contain one or more cannabinoids (e.g., THC and CBD), come in different strengths, and appear in a range of other delivery formats. It may be prescribed to relieve the symptoms of numerous medical conditions by interacting with the endocannabinoid system in the human body, producing a wide range of therapeutic effects.
The mechanisms of action of cannabis were a mystery until the discovery of the endocannabinoid system (ECS) in the human brain in the early 1990s, after researchers were studying how cannabis affects the brain. The Endocannabinoid System (ECS) is a complex signalling network that helps regulate vital bodily processes, such as sleep, appetite, pain, inflammation, memory, mood, and reproduction. The system comprises three major components, which include:
- Endocannabinoids are the signalling molecules of the ECS. The two main endocannabinoids are AEA (Anandamide) and 2-AG. These bind to two types of cannabinoid receptors (CB1 and CB2 receptors), causing different biological effects depending on the location of the receptor in the body.
- Cannabinoid type 1 (CB1) receptors are primarily found in the brain and spinal cord. They can also be found in the peripheral nerves, uterus, testis, bones and most body tissue.
- Cannabinoid type 2 (CB2) receptors are found in the peripheral organs and are especially associated with the immune system.
Enzymes and Proteins
- The ECS uses specialised enzymes and proteins to complete tasks to keep the system in check. Enzymes synthesise endocannabinoids on-demand in cells throughout your body and are also break them down after they carry out their specific tasks. Proteins are also used to transport endocannabinoids molecules from cell to cell.
Although much more research is needed, it is believed the ECS plays a key modulatory role to maintain homeostasis within the body. Dysregulation of the ECS is associated with various diseases such as chronic stress, anxiety disorders, epilepsy, autisms, cancer and chronic pain, to name a few.
Therefore how can we re-adjust this system?
The cannabis plant contains over 140 cannabinoids (known as phytocannabinoids), with THC and CBD being the most abundant and researched. Like endocannabinoids, THC and CBD can cause different results depending on the location of the receptor in the body and therefore be used to achieve specific therapeutic effects.
THC is typically the most abundant cannabinoid in the cannabis plant and is responsible for symptoms of intoxication. It partially binds with both CB1 receptors and CB2 receptors.
THC can cause intoxication as it mimics the endocannabinoid anandamide, binding to CB1 receptors in areas of the brain responsible for short-term memory, learning, problem-solving, and coordination. At high levels, this can lead to feelings of euphoria, relaxation and sleepiness. THC can be effective at lower levels without significant intoxication since it can bind to CB1 receptors in the brain and spinal cord to reduce sensitization and inflammation associated with pain.
THC can also bind to CB2 receptors expressed on immune cells, modulating anti-inflammatory effects (with 20-fold and 2-fold the anti-inflammatory effects of aspirin and hydrocortisone, respectively).
Numerous clinical trials are now underway investigating its use to treat chronic cancer and non-cancer pain, inflammation, spasticity, and nausea.
CBD is the second most abundant cannabinoid in the cannabis plant. It is not intoxicating and has been shown to reduce some of the unwanted intoxicating effects of THC.
Despite having a very similar chemical structure to THC, it does not bind to CB1 or CB2 receptors and instead changes the way the receptors respond to stimuli. Nevertheless, CBD has demonstrated many more properties which may explain its broad range of medical uses. CBD can boost levels of naturally occurring endocannabinoids by suppressing the enzyme (FAAH) responsible for their breakdown. It can also interact with various other receptors around the body (like serotonin, dopamine, and opioid receptors).
Because of its unique interaction with multiple receptors, CBD has been shown to modulate the immune system and reduce inflammation, pain, depression, anxiety, and help with addiction.
THC and CBD together?
There is increasing evidence suggesting that THC and CBD have a synergistic relationship when taken together, enhancing their therapeutic efficacy when treating specific conditions.
TGA has developed detailed clinical guidance documents that review the most substantial available evidence for the use of medicinal cannabis products in chronic pain, palliative care, epilepsy, spasticity in multiple sclerosis and chemotherapy-induced nausea and vomiting.
Evidence supporting the use of medicinal cannabis products for most other medical conditions is often of low quality. Nevertheless, there have been over 130 conditions approved for the use of medicinal cannabis via existing unapproved access pathways, primarily through the Therapeutic Goods Administration (TGA) Special Access Scheme Category B (SAS B). For more information on research supporting the use of medicinal cannabis for use in different medical conditions, visit the TGA’s website.
There is an increasing number of clinical trials investigating different medicinal cannabis formulations for a lot of conditions. Knowing how to navigate this can be overwhelming. You should discuss research and treatment options with your doctor. Your doctor can contact a Medlab Medical Science Liaison to provide clinical evidence to support the use of the product applications for many conditions.
Doctors rely on using evidence-based medications for the safety of their patients.
Currently, the level of evidence about the effectiveness of medicinal cannabis for use in different medical conditions is low-to-moderate since the products, doses and research methods used often vary between studies. The absence of evidence also reflects historical difficulties in undertaking clinical trials with cannabis products and the recency with which CBD has been identified as a therapeutic drug. This lack of information makes it difficult for doctors to determine how best to use specific medicinal cannabis products for a particular condition.
There is a significant need for high-quality clinical trials (e.g., randomised control trials) and studies to:
- Increase the quality of evidence to support or contradict the use of the product as an approved treatment for each medical condition.
- Understand the most effective medicinal cannabis products, doses and administration methods for treating different conditions
- Compare the efficacy of the medicinal cannabis product with conventional first-line treatment options currently used to treat each medical condition.
- Understand how the medicinal cannabis product interacts with other drug treatments, especially those commonly used for each medical condition.
Although the level of supporting evidence for medicinal cannabis for use in different medical conditions is of low overall quality, the evidence-based on first-hand patient experience must not be disregarded when approved treatments have been tried and have failed to manage conditions and symptoms.
Our commitement to research and patient access
Medlab Clinical is committed to undertaking rigorous clinical trials to assess the efficacy and safety of our NanoCelle® cannabis-based medicines. We are equally devoted to collecting real-world data (RWD) via our observational study and understanding the importance of providing compassionate access to meet the needs of patients who have no other options.
Medicinal cannabis is just like any other medicine. It may be a successful treatment for some people, but it won't be a successful treatment for everyone.
Despite being extremely unlikely to cause death on its own, medicinal cannabis can still have unpleasant side effects for some people who take it. Side effects vary with the medicinal cannabis product, the active ingredients (e.g. CBD, THC or combination) and between people.
Products containing THC may cause euphoria, sedation, vertigo, anxiety, dizziness, increased appetite, dry mouth, and impaired driving and cognitive function. In extreme cases, THC can cause depression, hallucinations, paranoid delusions, psychosis, and cognitive distortion (having thoughts that are not true). Doctors will prescribe very low doses of THC when people start treatment to minimise side effects.
CBD is generally well tolerated without serious side effects by itself but may interact with other prescription medications to alter their effects. Talk with your doctor if you are taking any other medicines or supplements.
Medicinal cannabis products can be classified as approved (registered) and unapproved (unregistered) products. Approved medicinal cannabis products are listed on the ARTG (Australian Register of Therapeutic Goods) registry and have undergone extensive clinical trials, and have had their quality, safety and effectiveness assessed by the TGA.
Except for two products, most medicinal cannabis products are not TGA approved medicines in Australia. The current process of prescribing unregistered medicinal cannabis products in Australia is highly regulated. Doctors who would like to access these unapproved products to treat appropriate patients may do so through TGA’s access pathways, outlined below:
Special access scheme
Grants approval for supplying unapproved therapeutic goods for a single patient:
- SAS category A: for patients who are seriously ill and death is likely to occur
- SAS category B: for all other patients who do not fit SAS-A definitions. This is the most common path for prescribing medicinal cannabis in Australia. SAS-B applications are typically processed within two days if all the necessary information is provided.
Authorised Presciber Scheme
Grants approval for a doctor to prescribe a specific product to a class of patients, rather than an individual patient (e.g. chronic non-cancer pain, multiple sclerosis, and palliative care).
You may also be able to access medicinal cannabis products through a clinical trial if your condition is currently being studied and you meet the study inclusion criteria. Talk to your doctor about whether there are any clinical trials starting that you may be able to enrol in.
Medlab clinical is undertaking a phase 3 clinical trial and an observational study investigating the safety and efficacy of a NanoCelle® (1:1 THC:CBD) cannabis-based formulation for the management of cancer and Non-cancer related pain.
There are no driving restrictions for people taking CBD only medicines.
There is zero tolerance for driving with the presence of Tetrahydrocannabinol (THC) in oral fluid, blood or urine, even if you don't feel impaired.
Patients taking prescription CBD-only medicines can lawfully drive as long as they are not impaired. However, like many other medications, Cannabidiol (CBD) can cause drowsiness, fatigue and in some instances lowered blood pressure when first commencing the medication. These symptoms are more common when the CBD is taken at high doses or with another interacting medication so extreme caution is required when operating heavy machinery or driving.
In Australia, there is zero-tolerance for driving with the presence of THC in oral fluid, blood or urine. Even if the driver has a prescription for medicinal cannabis and does not feel impaired, there is no exemption or legal defence for driving with even a trace of THC. THC can be detected in urine long after your last dose. It can take up to five days for 80 – 90% to be excreted from the body.
Unlike alcohol, a direct relationship between blood levels of THC and levels of driving impairment has not yet been established. THC can affect thinking and motor skills necessary for safe driving, such as attention, judgement, memory, vision, and coordination.
This situation is currently under review and will vary from one state to another. In the future, there may be exceptions granted for exemptions for patients with a legitimate medicinal cannabis prescription.
Talk with your doctor and/or pharmacist for more information.
One significant obstacle to accessing medicinal cannabis products is the cost. There’s currently no subsidy available for unapproved (non-ARTG) medicinal cannabis products under the Pharmaceutical Benefits Scheme (PBS).
Without a subsidy from the government, the high price of medicinal cannabis products makes them out of reach for many people since the patient is responsible for all costs associated with access. The cost of medicinal cannabis also depends on the type of product and the dose recommended by your doctor to treat each condition. For example, the typical daily dose required to treat epilepsy is much greater than that to treat anxiety.
As of today, there is currently only one medicinal cannabis product subsidised by the PBS. So why aren’t there more medicinal cannabis products on the PBS?
Before a registered medicinal cannabis product can be listed on the PBS for specific groups, more high-quality research and analysis are needed to demonstrate clinical effectiveness and determine cost-effectiveness compared to existing medicine listed. Product registration on the ARTG and listing on the PBS would significantly increase patient access.
At Medlab, we are committed to advancing patient access to cannabis-based medicines. We are running a phase 3 clinical trial and an observational study to examine the safety and efficacy of a NanoCelle® (1:1 THC: CBD) cannabis-based formulation for the management of cancer and Non-cancer related pain. Observational study participants will receive their NanoCelle® cannabis product at a subsidised rate for the duration of their participation in the study.