November 02, 2018, US
After fulfilling all the strict requirements of FDA, the first cannabinoid-based pharmaceutical drug has been finally put for sale in all 50 states of the US. The drug Epidiolex is manufactured by a UK-based pharma GW Pharmaceuticals and contains significant traces of CBD, a cannabinoid present in the cannabis plant. Even though the US government has allowed the sale of Epidiolex all across the country, but cannabis remains a Schedule I controlled substance in the federal law book.
Epidiolex: A regular prescription drug
Epidiolex is primarily developed to treat seizures caused by two rare form of epilepsies mostly affected minors. Several scientific studies have studied the effectiveness of CBD administration against epileptic seizures. This is the reason epilepsy is included in the list of qualifying conditions of every MMJ legal state.
However, it is important to make it clear here that Epidiolex is not an MMJ medication. It can be purchased like any other prescription medication and the patient won’t need any special permission to use it. Similarly, no federal and local cannabis laws will be applied to the distribution and sales of the drug. And like any other prescription medicine, Epidiolex can also be covered by insurance plans. In short, this CBD-based medicine is just another medicine on the shelves of pharmacies all across the US.
Epidiolex has gone through a thorough review and approval process before getting the status of prescription medicine. In April, the federal review committee initially approved the drug for FDA evaluation. In June, the FDA formally approved the drug after assessing all the research work provided by the GW Pharmaceutical. Lastly, the Department of Justice and the DEA gave the final signal of approval to Epidiolex in October.
Epidiolex is now classified as a Schedule V substance. The classification entails that the given substance can be prescribed as a medicine. Ironically, marijuana—the primary source of CBD—is still classified as Schedule I item. All the substances fall in this category supposedly have no therapeutic value and contain the high potential for substance abuse.
Cannabis advocacy groups are not getting their hopes high with this development, and rightly so. The approval to Epidiolex doesn’t suggest a change of heart of federal administration. Many experts are of the belief that it’s a one-off case and won’t lead to any major policy shift regarding cannabis. The inflexible stance of the federal government to not even relegating CBD or THC from Schedule I list is a clear manifestation of the fact that the business will remain as usual.
Some quarters are also questioning the exceptionally high prices of Epidiolex. As per media reports, the annual Epidiolex treatment cost can reach $32,500. Amid these concerns, GW Pharmaceutical maintains that the prices have been kept with other anti-seizure medications.
Some cannabis activists are also rightly asking how the price of the drug can be so high when it’s raw ingredient (marijuana or hemp) can be cultivated and processed at much cheaper rates. Many allege that the approval of Epidiolex is just another case of corporate favoritism by the government.
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