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 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.

DescriptionDate
Designation: Orphan22 November 2019
Designation: Priority18 December 2019
The submission dossier was accepted and the first-round evaluation commenced28 February 2020
Evaluation completed6 July 2020
Delegate’s overall benefit-risk assessment and request for Advisory Committee advice7 July 2020
Sponsor’s pre-Advisory Committee response21 July 2020
Advisory Committee meeting6 and 7 August 2020
Registration decision (Outcome)18 September 2020
Completion of administrative activities and registration on ARTG21 September 2020
Number of working days from submission dossier acceptance to registration decision*140

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