Tucson marijuana advocates applaud long-awaited FDA approval

FDA approves marijuana-based treatment

TUCSON, AZ (Tucson News Now) - She's well-versed in the menu and the products are well-tested. Having spent her valuable time and money at The Prime Leaf, near Speedway and Columbus boulevards, it's become Lise Hanson's safe shelter.

"I couldn't sleep. I hadn't slept in years," the Tucson woman said.

After several years confined to a wheelchair, suffering from Scoliosis, intense surgery got her back on her feet. But the recovery left her addicted to prescription pain pills and narcotics, she said.

Now years later, and years happier thanks to her prescription treatment with cannabis-based products, she can understand why others might be more hesitant than she.

"CBD products could help so many people. But they're scared because they don't want marijuana," Hanson said.

An FDA decision on Monday was really exciting news for The Prime Leaf's CEO, Brian Warde.

"It's going to be a game changer for the cannabis industry, and I think cannabis as a whole," he said.

The U.S. Food and Drug Administration announced Monday, June 25, that it's approved a marijuana-derived drug for the first time. The drug, Epidiolex, contains a chemical from the Cannabis sativa plant called cannabidiol, or CBD.

The administration pointed out that unlike THC, a more well-known chemical component of marijuana, CBD doesn't cause intoxication.

It's the first time that the federal organization has approved a marijuana-based drug.

Warde was surprised it took so long.

"I think it's been a long time coming for a lot of people in the industry and people who have worked with patients and seen some of the impacts on people's lives. I don't think it was that shocking. It's effective," he said. "I think it's a great step for the FDA. But it's a little behind where the rest of the world is."

FDA Commissioner Scott Gottlieb said in a statement that while the announcement represents a significant scientific achievement, the public shouldn't take it as an overall stamp of approval for marijuana, a Schedule 1 drug with known risks, that is illegal at the federal level.

Epidiolex is a twice-daily oral solution, which doctors can prescribe to treat seizures related to Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of epilepsy.

An FDA advisory committee recommended approval of Epidiolex in April; it had until this week to make a decision on the recommendation.

Patients age 2 years and older will be able to use the drug.

Other brand-name CBD oils were already being sold legally under Arizona law at The Prime Leaf.

"Most of them are looking for some alternative to another prescription drug or narcotic and they are always looking to find that balance of life and comfort," Warde said.

The FDA commissioner said the "path that made this possible" is "a path that's available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs."

"This is an important medical advance. But it's also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use," Gottlieb said.

Warde believes the recent FDA approval will have more patients in doctors' offices asking about the effects.

"But those physicians will dictate what happens in research. That is great for everyone that is in the industry. I mean, I think everybody who got into this industry really looked at helping people. The bottom line is to help people. We put that first."

People like Hanson, with her prescription cannabis card, are given a little more hope.

"Because there's something they can try - something else they can try," she said.

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