Maker of First FDA-Approved Cannabis Drug Updates Roll-out Plans

GW Pharmaceuticals, the manufacturer of CBD drug Epidiolex, is making plans to bring its THC drug Sativex to the United States, pending regulatory approval. Epidiolex became the first medicine derived directly from cannabis to be approved by the FDA.

Sativex is an oral spray medication with 1:1 ratio of THC to CBD. GW Pharmaceuticals, a UK firm, first received approval for Sativex in the United Kingdom in 2010 as a treatment for spasticity caused by multiple sclerosis. Currently, the drug is approved for use in more than 30 countries worldwide to treat symptoms of multiple sclerosis and pain. But until now, the company has “never engaged with the FDA to get it approved in the US,” GW CEO Justin Gover recently told Business Insider.

“We now plan to meet with the FDA and determine a path forward,” he added.

Because Sativex has already been used successfully by patients around the world, approval in the US presents “a very late-stage opportunity for which we’ve generated a lot of data,” Gover said. “And it has a lot of potential, both for MS and neuropathic pain and potentially for other neurological conditions as well.”

Sativex Already Approved in 30 Countries

Although GW is just beginning the FDA approval process for Sativex now, the company has planned to market the drug in the US for more than a decade. In 2007, the firm signed an exclusive licensing agreement with Japanese pharmaceutical company Otsuka to develop and market Sativex in the United States. But at the end of last year, GW announced that the two companies had reached an agreement to end the relationship.

Under the terms of the arrangement, GW regained the rights to the US market for Sativex without having to make an upfront payment to Otsuka. Payments to the Japanese firm will be made, however, once the drug is approved in the US and again upon reaching certain sales benchmarks.

At that time, Gover hinted that seeking FDA approval was on the horizon.

“We are pleased to have amicably reached this agreement with Otsuka, which enables GW to develop, seek approval for, and commercialize Sativex in the United States,” said Gover.

The CEO of GW also said that the results of research the company has already conducted should help speed the approval process.

“We have previously conducted several positive Phase II and III trials for Sativex and believe that this product represents an important new late-stage pipeline opportunity for GW in the US market,” Gover said.

First Cannabis Drug Approved in June

GW Pharmaceuticals made history earlier this year when Epidiolex became the first drug derived directly from cannabis to receive regulatory approval from the FDA. The medicine was approved as a treatment for Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The two debilitating forms of childhood epilepsy can cause dozens or even hundreds of seizures per day and often cannot be treated successfully with other medications.

Just last week, the US Drug Enforcement Administration announced that is classifying Epidiolex and as a Schedule 5 drug under the Controlled Substances Act. However, the cannabis plant, CBD, THC, and other cannabinoids remain in Schedule 1.