Parents of children suffering from epileptic seizures will likely take heart from the announcement yesterday from GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) of promising results from phase 3 trials of its Epidiolex childhood epilepsy drug.
Epidiolex is a drug derived by GW Pharma from cannabidol (CBD), found in marijuana, colloquially referred as ‘pot.’
The GW Pharma stock surged 17.20% higher Monday to $126.06 with 3.35 million shares traded, and this
GW Pharmaceuticals PLC- ADR(NASDAQ:GWPH) : “Hugely Important Potential Breakthrough”
The phase 3 clinical trials for Epidiolex showed that pediatric epileptic patients taking 20 mg of the drug gained a medium reduction in monthly seizures of 42% compared to only 17% from a placebo.
“The impact that we have had that we have shown today is a hugely important potential breakthrough in the treatment of the condition called Lennox-Gastaut syndrome,” GW Pharma CEO Justin Gover told the host of CNBC’s Mad Money.
The Lennox-Gastaut Syndrome (LGS) is a rare form of childhood epilepsy with multiple different types of seizures.
In June 2016 GW Pharma announced positive results in the first pivotal Phase 3 trial of Epidiolex for the treatment of seizures associated with LGS, and in March 2016, encouraging results in the treatment of seizures associated with Dravet syndrome.
Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy, is a rare and catastrophic form of intractable epilepsy that begins in infancy.
Epidiolex has already been granted an orphan drug designation by the FDA – a special status for the treatment of a rare disease or condition.
These developments position GW Pharma for the submission of a New Drug Application (NDA) to the USFDA in the first half of 2017. If this is successful, the company might be able to bring the drug to the US market by early 2018.
Researchers at Cantor Fitzgerald reaffirmed their Buy rating on GW Pharma and moved their price target from $165 to $182.