GW prepares US for cannabis-based epilepsy drug

Shares in GW Pharmaceuticals have jumped after its cannabis-based drug Epidiolex got a positive review from FDA staff for rare forms of child epilepsy.

The company is already making legal arrangements to get the drug prescribed, with laws in some US states presenting obstacles to its use, even though the treatment doesn’t have significant potential to be abused.

The regulator’s Peripheral and Central Nervous System Drugs Advisory Committee is due to meet tomorrow to make a non-binding judgement on whether the drug should be approved.

And a briefing document prepared by the regulator’s reviewers ahead of the meeting suggest that this potential blockbuster drug could be on the cusp of approval, as although the FDA does not have to follow the advice of its committees, it usually does.

The reviewers’ verdict on Epidiolex was clear – that evidence from phase 3 trials in Lennox-Gastaut syndrome and Dravet syndrome is sufficient for approval, with the drug’s benefits outweighing its risks.

Authors concluded: “The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with LGS and DS.

“Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with LGS and DS.”

 

A positive vote from the committee now looks like a formality, paving the way for a decision from the FDA before a legal deadline of 28 June.

Legal barriers

And according to reports, GW is already working overcoming the legal and cultural barriers to a drug based on cannabis in the US.

Epidiolex is given as a syrup and is a purified form of cannabidiol, one of the active ingredients in marijuana.

But it contains less than 0.1% of tetrahydracannabidiol, the substance that makes people high.

Epidiolex is not classed as medical cannabis, which is still illegal in a handful of states, but is caught up in conflicting legislation regarding cannabis-based medications in some states.

For instance in Colorado, a series of conflicting regulations have created a ‘Catch-22’ situation, as pharmacies are not allowed to sell cannabis medications, and cannabis dispensaries cannot sell FDA-approved drugs because they are not licensed pharmacies.

However according to the website Cannabis Law Report, GW has introduced a bill into the state’s general assembly to resolve the problem and allow it to be prescribed at pharmacies, which already has the support of senior state politicians from both the Democrat and Republican parties.

Under current arrangements patients could still get the medicine after a doctor prescribed it, however.

 

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