GW Pharmaceuticals PLC (NASDAQ: GWPH) was one of the stocks surging on Friday, on news that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation status to the company’s Epidiolex. This is GW’s investigational cannabidiol product used to treat a rare form of childhood epilepsy called Dravet syndrome. While this is huge news for GW, one cannot help but wonder if this means that the FDA is finally opening up to the potential drug treatments of cannabinoid products.
We would point out that GW Pharma did note that Epidiolex has already received orphan drug designation from the FDA. Also, the U.K.-based company’s Sativex is already on the market in 11 countries as a treatment for spasticity due to multiple sclerosis, and it is also in development in cancer pain and neuropathic pain.
The FDA’s Fast Track program means that the drug under review targets serious medical conditions and fills an unmet medical need. Drug development programs that have received the Fast Track designation are generally given greater access to the FDA for the purpose of expediting the drug’s development and FDA review. This also implies a much faster potential drug approval process, assuming that approval is actually granted.
GW has already opened an Investigational New Drug for Epidiolex, and the company said that it is on track to begin a Phase 2/3 clinical trial in Dravet syndrome in the second half of this year. The company further said about another indication:
In addition to Dravet syndrome, GW plans to conduct a clinical development program for Epidiolex in the treatment of Lennox-Gastaut syndrome (LGS). Following receipt earlier in 2014 of orphan drug designation by the FDA in LGS, GW expects to hold a pre-IND meeting with the FDA for Epidiolex in the treatment of LGS in mid-2014, and expects to conduct two Phase 3 trials in LGS during 2015.
What this all implies is that the FDA must be getting at least somewhat more receptive to approving drugs that are considered cannabinoid products.
GW Pharmaceuticals shares were up 8% to $73.56, on more than 1.6 million shares after the first 90 minutes of trading Friday. Keep in mind that its 52-week range is $8.46 to $86.45. Its current market cap is almost $1.3 billion.