Marijuana-Derived Drug to Be Approved by FDA

Marijuana-Derived Drug to Be Approved by FDA

There are some American parents who have been treating their children’s epilepsy with cannabis, however, they are feeling cautious about U.S. regulators who are near a decision to approve the first drug that came from the marijuana plant.

Epidiolex is made by GW Pharmaceuticals and is a purified form of cannabidiol (CBD), which is a component of marijuana that does not get patients high. It is being used to treat children with Dravet and Lennox-Gastaut syndromes. Both syndromes are rare forms of epilepsy.
The U.S. Food and Drug Administration is expected to make a decision on the drug by the end of June 2018.

marijuanaThe positive effects of cannabidiol on a variety of health conditions is frequently praised, but there is still little evidence to back up personal experiences. Marijuana has been categorized as a Schedule I drug, which makes it difficult to research. Schedule I means the drug has “no currently accepted medical use and a high potential for abuse.”

However, parents who are desperate to find anything to help their children have turned to marijuana-based products, which have been made legal in a variety of states.

Meagan Patrick is one of the parents who uses CBD to treat her children’s symptoms. Her daughter has a brain malformation that causes seizures. Patrick moved from Maine to Colorado in 2014, so she could have legal access to CBD for her now-five-year-old daughter.

Nevertheless, Patrick is fearful of the drug Epidiolex being legalized by the FDA.

I want to make sure that her right to continue using what works for her is protected, first and foremost. That’s my job as her mom.

Advocates became concerned when GW Pharmaceuticals began to lobby for change in states’ legal definition of marijuana, beginning in 2017, with proposals in Nebraska and South Dakota.

Some advocates are worried that the company’s attempt to ensure its product can be legally prescribed and sold by pharmacies would have a negative side effect: curtailing medical marijuana programs that are already operating.

In general, the proposals sought to remove CBD from states’ legal definition of cannabis. This would allow it to be prescribed and supplied by pharmacies. But this change would only apply to FDA-approved products.

marijuanaNeither South Dakota nor Nebraska have legalized medical marijuana. Activists have accused the drug manufacturer of trying to close down any future access to products containing CBD but lacking the approval of the FDA.

Britain-based GW Pharmaceuticals did not intend for the changes to affect other cannabis products. The changes, however, are necessary for Epidiolex to be sold in pharmacies and prescribed to patients, according to spokesman Stephen Schultz.

Schultz would not talk about other places the company plans to seek changes in state law. However, the Associated Press was able to confirm that lobbyists for Greenwich Biosciences has backed legislation in Colorado and California.

The spokesman stated, “As a company, we understand there’s a significant business building up. All we want to do is make sure our product is accessible.”

According to industry lobbyists in Colorado and California, they take company officials at their word, but insisted on protective language that would ensure recreational or medical marijuana, cannabidiol, hemp, and other products derived from cannabis plants will not be affected by the changes GW Pharmaceuticals seek.

Attorney Patrick Goggin focuses on industrial hemp issues in California. He stated that GW Pharmaceuticals would run into issues if it tried to “lock up access” to cannabis-derived products beyond FDA-approved drugs.

People need to have options and choices. That’s the battle here.

The changes are logical according to legal experts. The laws in some states prohibit any product derived from the cannabis plant from being sold in pharmacies. The FDA has approved a synthetic version of a different marijuana ingredient to be used for medical purposes, however, it has not approved cannabis or hemp for any medical uses.

marijuanaIn April, a panel of FDA advisers unanimously recommended that the agency approve Epidiolex for the treatment of severe seizures in children who have epilepsy. The conditions are difficult to treat otherwise.

It is unclear how or why CBD reduces the number of seizures in some patients. The panel made its recommendation based on three studies that show significant reduction in children with two forms of epilepsy.

Denver-based attorney Christian Sederberg worked on the GW Pharmaceuticals-backed legislation in Colorado on the behalf of the marijuana industry. He believes that all forms of cannabis can exist together.

The future of the industry is showing itself here. There’s going to be the pharmaceutical lane, the nutraceutical (food-as-medicine) lane, and adult-use lane. This shows how that’s all coming together.

Alex and Jenny Inman have a son who has Lennox-Gastaut syndrome, but they will not be switching him to Epidiolex if it becomes available.
The Inmans said it took some home experimentation to find the right combination of prescribed medications, CBD, and THC to help their son with his seizures.

What makes me a little bit nervous about this is that there’s sort of a psyche amongst patients that, ‘Here’s this pill, and this pill will solve things,’ right” It works differently for different people.

In 2015, the Inmans moved to Colorado from Maryland. The decision came after doctors recommended their son undergo a second brain surgery. It is commonly understood among parents, who have children with epilepsy, that children react differently to different strains.

The Realm of Caring Foundation is an organization that was co-founded by Paige Figi. Her daughter, Charlotte, has a name attached to the CBD oil Charlotte’s Web. The organization maintains a registry of 46,000 people who use CBD worldwide.

Heather Jackson said her son benefited from CBD and she also co-founded the Realm of Caring Foundation. She says the approval of Epidiolex means insurance companies will begin paying for the cannabis-derived treatment.

That might be a nice option for some families who, you know, really want to receive a prescription who are going to only listen to the person in the white coat.

By Jeanette Smith


Chicago Suntimes: Parents worry US approval of pot medicine might undo patchwork of state laws
NBC News: Some parents wary of cannabis-based medication for epilepsy

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