Summary for ARTG Entry: 328860 Epidyolex cannabidiol 100 mg/mL oral liquid solution bottle
ARTG Name
EPIDYOLEX cannabidiol 100 mg/mL oral liquid solution bottle (328860)
Product name
EPIDYOLEX
ARTG Date
21 September 2020
Registration Type
Medicine
Therapeutic good type
M
Sponsor
Chiesi Australia Pty Ltd
Ingredients
cannabidiol
Licence category
RE
Licence status
A
The medicinal product Epidyolex contains the active substance cannabidiol, which can be used for the treatment of seizures (epilepsy). It has been proven to work well across all ages from 2 years old up until adult maturity! Epidyolex treats a rare disease known as Lennox Gastaut syndrome or Dravet’s Syndrome, which affects only 1 out of 1000 people. The disease manifests as a type of epileptic fit.
Mode of action
Cannabidiol, a chemical found in medical cannabis has been reported to have anti-seizure properties. The drug reduces the frequency at which seizures occur and can help with other types of epilepsy as well but there’s no concrete proof yet on how this works so we don’t know exactly why CBD oil works as PTSD does or if both conditions share any commonalities aside from being neurological disorders caused by inflammation within your brain tissue.
A recent study published last year showed a significant reduction after just four weeks when patients took 1 gram per day (or 30 milligrams total) versus those who didn’t receive supplementation – meaning you might see results faster than expected!
Use
Epidyolex, a prescription-only medicine containing cannabidiol, is supplied in 100 ml bottles with two dosing syringes (1ml and 5 mg). Each dose consists of 1000mg CBD oil or 100 mg per serving which may be taken twice daily as a long-term treatment.
Efficiency
In this study, 456 patients with Dravet syndrome or Lennox-Gastaut Syndrome were treated by giving either Epidyolex at 10 mg/kg body weight per day in two dosages (20mg total) or placebo. The researchers found that while both groups experienced some improvement; there was a significant difference between how well they did when taking the drug compared to not receiving any treatment whatsoever.
The drugs used in two different studies with DS patients showed that they could reduce the number of convulsive seizures, which is a serious type of seizure where you lose consciousness. In these same trials, LGS sufferers also saw improvement when taking Epidyolex compared to placebo; this includes short-term loss-of muscle tone and impaired mental status leading up to sudden falling down named “fall attacks”. All four tests conducted by doctors resulted in a reduction of around 40 – 50%.
Precautions, undesirable effects & risks
The active substance in Epidyolex is not available to those who are sensitive. It also has several other excipients, like sesame oil which may cause reactions in some people and should be avoided if possible.
When patients take Epidyolex, their liver enzymes may be elevated. This is an early sign of unknown origin and could mean that there’s been some kind of injury to the organ resulting in elevated transaminase levels.”
The liver enzyme levels must be checked at regular intervals so that any hepatic disorders are detected.
The most common side effects (affecting 10% or more) are somnolence, decreased appetite and vomiting. Other symptoms include diarrhoea or pyrexia in some patients which can lead to feverishness on its own as well if it’s not treated promptly!
Taking Epidyolex with food can increase the number of drugs absorbed by your body. This is because when you take it, certain nutrients in foods help break down medications so they work better for us! If possible always have a meal or snack while using this medication.
Try to consume at least 3 hours after administration any time between doses if needed due caution measures are necessary during pregnancy though there’s no evidence showing what kind would make sense given our current situation here just something worth mentioning since most women get really tired easily sometimes even without doing anything physical too much.
The ability to drive and use machines is impaired during treatment with Epidyolex.
The prescribing information (Information for healthcare professionals) and the Information for patients lists all precautions, risks and other possible undesirable effects.
Why the medicinal product has been authorised
The treatment with Epidyolex has shown to be effective in patients suffering from Lennox-Gastaut syndrome or Dravet’s Syndrome. Taking precautions such as liver enzyme checks, the risks associated can usually be viewed as acceptable for those who require this drug therapy. Cannabidiol was Legalised in 2018 opening the gateway for others to follow suit, The Green Doctor was another company that followed suit.
The output should include information about how many people are helped by using it and detail what they need to do beforehand.
Since both of these syndromes are rare diseases, the medicine has been authorised as an orphan drug.
Orphan drugs are medicines that have been specifically developed for rare diseases. These products benefit from reduced authorisation conditions, meaning they can be brought to market more quickly than other types of drugs would usually undergo approval processes.
Healthcare professionals (doctors, pharmacists and others) can answer any further questions about this medicine.
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Designation: Orphan | 22 November 2019 |
| Designation: Priority | 18 December 2019 |
| The submission dossier was accepted and the first-round evaluation commenced | 28 February 2020 |
| Evaluation completed | 6 July 2020 |
| Delegate’s overall benefit-risk assessment and request for Advisory Committee advice | 7 July 2020 |
| Sponsor’s pre-Advisory Committee response | 21 July 2020 |
| Advisory Committee meeting | 6 and 7 August 2020 |
| Registration decision (Outcome) | 18 September 2020 |
| Completion of administrative activities and registration on ARTG | 21 September 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 140 |
