GW Pharmaceuticals gained an advantage over Tilray with DEA scheduling of Epidiolex on Thursday.
Publicly traded GW Pharmaceuticals had a monumental win on Thursday. The company’s cannabis-derived epilepsy drug, Epidiolex, landed a classification from the federal Drug Enforcement Administration (DEA) that will allow sales throughout the United States.
Marking a significant first for the DEA, Epidiolex is the first drug containing marijuana to receive Schedule V status, the least restrictive of all categories on the controlled substances list. Cannabis has been strictly a Schedule I controlled substance since the categories were established by Congress in 1079 with the Controlled Substance Act.
While the scheduling of Epidiolex does not immediately affect the Schedule I status of marijuana, it directly challenges the classification. Schedule I drugs are listed as having no known medical benefits. This week, with the classification of Epidiolex, the DEA recognized that a chemical in marijuana is medicine.
The DEA’s decision was influenced by successful clinical trials of the drug conducted by GW Pharmaceuticals. The trials were able to demonstrate that the cannabis-derived compound can reduce seizures in two difficult-to-treat forms of childhood-onset epilepsy, Dravet syndrome, and Lennox-Gastaut syndrome.
In contrast, the marijuana pharmaceutical Marinol, which is used to treat vomiting and nausea caused by chemotherapy, is a Schedule III drug.
The news has major implications for GW Pharmaceuticals stock. It is now the only CBD producer with a formula that will be available nationwide by prescription. The company plans to launch the drug before the end of October.
Though only around 30,000 patients are diagnosed with Dravets syndrome or Lennox-Gastaut syndrome, the company believes it will grow in time as doctors begin to prescribe Epidolex off-label for patients with other forms of seizures.