October 03, 2018
GW Pharmaceuticals is a UK-based medicine company extensively researching and developing drugs from cannabis. The company has the distinction to introduce first FDA-approved drug in the US called Epidiolex. This cannabis-based medicine is actually derived from CBD and developed to treat some rare medical conditions for which conventional pharmaceutical products fail to produce significant therapeutic results.
GW is now vying to introduce its second cannabis-derived drug Sativex in the US market. Like before, the company first has to go through rigorous regulatory and review process of the FDA. It is worth mentioning that Sativex is not just a CBD-only medicine. It also contains THC in equal parts. THC is the cannabinoid responsible for the high associated with cannabis. Presence of THC is the major reason why marijuana is classified as a Schedule 1 controlled substance in federal law. It will be interesting to see how the premium federal regulatory authority will review and approve the medicine that contains THC as a major constituent.
Sativex is not a recently developed cannabis medicine. It received its first approval in the UK eight years ago. The drug was initially developed to treat particular muscular contractions caused by multiple sclerosis. Due to its effective therapeutic action against the condition, Sativex is now an approved medical treatment in over 30 countries.
Over the years, this THC-CBD drug has also been studied for other therapeutic actions as well. It is also believed to treat the condition of neuropathic pains and got the potential to treat other neurological conditions too. According to CEO of GW Pharmaceuticals Justin Gover, the company is planning to meet FDA for the approval of Sativex. The company is hopeful to have a fruitful conclusion of the FDA meeting. This optimism exists due to all the data generated over the years substantiating the therapeutic benefits of the drug and the success of multiple Phase II and Phase III trials of the drug.
Even though the company is just initiating the process of FDA approval, but it has already worked out the plan to develop and market Sativex in the US market. GW Pharmaceuticals earlier gave a Japanese-based pharmaceutical company the right to take control of the US market of Sativex.
However, at the end of last year, the company has canceled this MoU and reclaimed the rights to the US market for Sativex. It is important to note the rights to develop and sell Sativex will be given back to the Japanese pharmaceutical when its sales will reach a certain target.
GW Pharmaceuticals has made significant progress in the US market this year. In an unprecedented turn of events, GW’s cannabis drug Epidiolex became the first FDA-approved in the US. Epidiolex is developed to treat two rare forms of childhood epilepsy that can result in hundreds of seizures daily. The drug is classified as Schedule 5 substance by the FDA whereas it’s major constituent CBD continues to share Schedule 1 classification with addictive and deadly substances such as heroin and MDMA.
Marijuana stays in the news, and Alice is always ready to keep us updated. A world traveler and lover of freedom, Alice knows what is going on, no matter where she roams. She specializes in marijuana legalization stories across the globe, with up to date... [read more]