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GW Pharma's cannabis-based Epidyolex edges closer to EU approval with positive CHMP opinion in epilepsy

UK-based biotech GW Pharmaceuticals has announced that its cannabidiol oral solution Epidyolex has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The specialist panel chose to endorse the therapy and push for its approval, in combination with clobazam, as an adjunctive treatment for seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome in patients at least two years old.

GW Pharma's Epidiolex scores in rare childhood onset epilepsy Phase 3 trial

GW Pharma’s Epidiolex has shown positive Phase 3 trial results for the fifth time in a row, after meeting primary endpoints in a randomised, double blind, clinical study of patients with Tuberous Sclerosis Complex (TSC), a rare form of childhood onset epilepsy.

The CBD-based drug reduced seizures by 48.6% and 47.5% from baseline at doses of 25 and 50 mg/kg/day in patients with TSC, compared to a rate of 26.5% for placebo.

Australian firm Althea enters UK medicinal cannabis market

Melbourne-based medicinal cannabis company Althea has become one of the first companies to enter the UK market after the British government made cannabis products available on prescription.

Althea will supply the UK in a partnership with Canadian firm Aphria, one of the largest medical cannabis supplies around the world. The deal will last until 2020 at which point Althea’s Australian production facility is expected to become fully operational.

Having set up an office in London Althea says it will begin supplying the UK with cannabis by next month.

GW Pharma's Epidiolex becomes first cannabis-based medicine to be made available in United States

GW Pharma’s Epidiolex has become the first plant-derived, cannabis-based medicine to be made available on prescription in all 50 US states. The medication consists of highly-purified, plant-derived cannabidiol (CBD).

The twice daily oral solution was approved by the FDA for the treatment of seizures associated with either Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients aged 2 years and older in June of this year; however the CBD based drug will now be available to patients across the United States.

Zynerba's cannabis-based transdermal patch fails at Phase 1, shares slide 21%

Image Credit: Michel Porro/Getty Images

As public focus on the issue of medicinal cannabis continues to grow, Zynerba Pharmaceuticals has announced that its transdermal tetrahydrocannabinol (THC) patch ZYN001 has failed in Phase 1 trials to achieve targeted levels of THC in the blood of patients.

Zynerba attempted to assess the efficacy of a range of dosages and wear times in 60 participants, who wore the patches for a duration of between 24 hours and two weeks, but the drug did not hit the target levels of 5ng/ml to 15ng/ml of THC. The news caused the company shares to plummet 21%.

GW Pharma's Epidiolex becomes first cannabis-based medicine available in US

In what could prove to be a pivotal decision, UK biotech GW Pharmaceuticals has announced that its oral cannabidiol solution Epidiolex has been awarded marketing approval in the US by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older.

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FDA advisory committee sets GW Pharma up for approval

After the FDA advisory committee unanimously recommended GW Pharma’s Epidiolex for approval, the chances of it not receiving the nod are now slim to none.

All the data released by GW Pharma had pointed towards a strong case for approval, with a number of Phase 3 trials having been conducted to prove the drug’s efficacy in treating Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).

However, there has always remained one question mark – would the FDA approve a treatment that is derived from cannabis?

All indications point to approval for cannabis-based therapy

GW Pharma are inching step by step towards a likely approval with the FDA, after it received a strong recommendation within a briefing document prior to the FDA advisory committee meeting.

GW Pharma’s is seeking indications for two conditions of childhood epilepsy, Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), for its treatment, Epidiolex. The epilepsy drug is derived from cannabidiol in a purified form and is delivered to patients as a syrup.

GW Pharma boasts new positive data, readying for approval

The latest data from GW Pharma is about as conclusively positive as you can usually hope to get with a new drug, smashing performance against placebo on both primary and secondary endpoints.

The stage looks set for the first approval of a cannabis-derived product, barring any unexpected surprises. Uncertainty over how a drug made from a plant that is designated as a Schedule I by the DEA, which means that it is regarded as having no potential medical value, has never really left the background of the GW’s work.

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