U.S. approves first prescription drug made from marijuana

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The FDA approved a CBD-based medication to treat two rare forms of epilepsy that begin in childhood

WASHINGTON — U.S. health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

The Food and Drug Administration approved the medication, called Epidiolex, to treat two rare forms of epilepsy that begin in childhood. But it’s not quite medical marijuana.

The strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant — but not the one that gets users high. It’s not yet clear why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.

British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis.

FDA officials said the drug reduced seizures when combined with older epilepsy drugs.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV.

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. CBD is one of more than 100 chemicals found in marijuana. But it doesn’t contain THC, the ingredient that gives marijuana its mind-altering effect.

Physicians say it’s important to have a consistent, government-regulated version.

“I’m really happy we have a product that will be much cleaner and one that I know what it is,” said Ellaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy. “In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.

Several years ago, Allison Hendershot considered relocating her family to Colorado, one of the first states to legalize marijuana and home to a large network of CBD producers and providers. Her 13-year-old daughter, Molly, has suffered from severe seizures since she was 4 months old. But then Hendershot learned about a trial of Epidiolex at New York University.

“I preferred this to some of those other options because it’s is a commercial product that has gone through rigorous testing,” said Hendershot, who lives in Rochester, New York.

Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer “drop” seizures — in which her entire body goes limp and collapses.

CBD oil is currently sold online and in specialty shops across the U.S., though its legal status remains murky. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

The impact of Monday’s approval on these products is unclear.

The FDA has issued warnings to CBD producers that claimed their products could treat specific diseases, such as cancer or Alzheimer’s. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

Most CBD producers sidestep the issue by making only broad claims about general health and well-being.

Industry supporters downplayed the impact of the FDA approval.

“I don’t know a mom or dad in their right mind who is going to change what’s already working,” said Heather Jackson, CEO of Realm of Caring, a charitable group affiliated with Colorado-based CW Hemp, one of nation’s largest CBD companies. “I really don’t think it’s going to affect us much.”

Jackson’s group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance.

[ Game of Pain: Why Jake Plummer and others are pushing for research on CBD’s benefits to NFL players ]

A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall. Wall Street analysts have previously predicted it could cost $25,000 per year, with annual sales eventually reaching $1 billion.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few treatments. But doctors will have the option to prescribe it for other uses.

The new medication enters an increasingly complicated legal environment for marijuana.

Nine states and the District of Columbia have legalized marijuana for recreational use. Another 20 states allow medical marijuana, but the U.S. government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. Last year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.

GW Pharmaceuticals makes the drug in the U.K. from cannabis plants that are specially bred to contain high levels of CBD. And the company plans to continue importing the medicine, bypassing onerous U.S. regulations on manufacturing restricted substances.

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Kristen Bell Says CBD Lotion Helps Her Sore Muscles

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Kristen Bell’s post-workout go-to? The Lord Jones High CBD Pain & Wellness Formula Body Lotion ($50; lordjonesbrand.com). CBD oil, a substance made by extracting a specific compound from cannabis called cannabidiol, has been making headlines lately for its benefits in beauty, wellness, and more.

“I love my @thelordjones body lotion for my sore muscles after working out,” Bell shared with her Instagram followers after hitting the gym on Tuesday.

Fear not: CBD is non-psychoactive, so you won’t get high from using products like this. They’re also widely available in the U.S. But what do experts say about them?

“It may have pain-relieving capabilities, but we’re still waiting for good clinical studies to prove this,” Health’s medical editor, Roshini Rajapaksa, MD, previously wrote of CBD oil. “It’s possible that a few drops of CBD oil can be therapeutic, but we need more info on what it’s really useful for. Some research has shown that CBD may be effective for relieving chronic pain, as well as pain associated with cancer treatment and arthritis. It’s not entirely clear how CBD may work to alleviate pain; it may be related to the compound’s anti-inflammatory properties.”

Research suggests that marijuana products are effective at treating chronic pain, calming muscle spasms caused by multiple sclerosis, and easing nausea from chemotherapy. However, you may not find relief in your muscles.

As Ricardo Colberg, MD, a physician at Andrews Sports Medicine and Orthopaedic Center in Birmingham, Alabama, told Shape, topical creams won’t reach the muscle where your actual soreness is located.

“Any cream with a heating or cooling sensation desensitizes the nerves to pain by distracting them with stimuli on top,” he said, and the Lord Jones CBD lotion falls into that camp. But it’s not all bad news: “Scientific literature says there’s a 33% chance of the placebo effect helping people, so for some, just using a cream they believe can help will provide some relief,” Dr. Colberg added.

If cannabis cream helps Bell in her post-workout recovery, it could help you, too. We’re still waiting on more scientific evidence, but if you have $50 to spend and you’re curious, there’s virtually no medical risk in rubbing some on your sore muscles.

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Livingston Pharmacy Now Offering CBD Oil

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LIVINGSTON, NJ – Livingston Pharmacy has become one of the first pharmacies in New Jersey to carry CBD, a 100 percent legal and not addictive or psychoactive product.

Cannabidiol (CBD) has worked its way into health food stores, gyms, and now, independent pharmacies throughout the country. Livingston Pharmacy is carrying one of the most highly regulated and potent products on the market. Shipped directly from a farm in Kentucky, the product is kept behind the pharmacy counter, but can be sold without a prescription.

“Ever since CBD oil became legal, we have received tons of questions and requests for it,” said Becky Ruditser, owner and pharmacist in charge at Livingston Pharmacy. “We never felt comfortable with such products until this farm approached us. We have had wonderful results and are hopeful and eager for continued success with it.”

CBD Oil has been shown to have positive effects on pain relief, anxiety, insomnia, GI upset and much more. The pharmacists at Livingston Pharmacy have studied and trained on the topic, giving them the ability to answer many questions and concerns regarding the product.

“We’ve seen strong growth with the CBD Oil and have had lots of positive feedback,” Ruditser said. “It’s a great alternative to pain medication and an added benefit to many different disease states. We’re very excited about it!”.

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CBD store owner provides unique perspective on medical marijuana debate

OKLAHOMA CITY – As the state of Oklahoma nears the medical marijuana vote – a tale of two perspectives.

One of them is a doctor and state senator who supports medical marijuana but not State Question 788. The other is the owner of a CBD store who said he will vote yes but there is a twist.

EJ Bancroft sells CBD products at his CannaHealth of Oklahoma stores. He said he will be voting for SQ 788 and will sell some of the products it legalizes.

However, he said you’ll never see smokable marijuana on his shelves.

“There’s nothing you can get from smoking pot that you can’t get from any of these products,” Bancroft said.

He said, when a person smokes marijuana, the effect is more psychoactive than medicinal.

He said that’s because the consumer gets higher levels of THC than CBD due to the simplicity of its processing as compared to that of infused products.

“There’s no extraction processes, quality control, anything like that,” Bancroft said. “You just cut it from the plant, stick it in a jar and sell it to the end user.”

Bancroft said he thinks SQ 788 is too vague in terms of regulations but will still vote yes on Tuesday in hopes more regulations will be added.

“It’s not like we’re going to vote it in tomorrow and, the next day, everybody’s walking the streets smoking a joint,” he said. “It’s not going to work that way.”

Senator Ervin Yen, who is a doctor, authored a bill in the past to legalize medical marijuana and the bill that legalized CBD, but he is voting no on SQ 788.

“I’m for CBD and medical marijuana,” Yen said. “That’s why I wrote a medical marijuana bill two years ago, but I’m absolutely opposed to 788 because it’s not medical.”

Yen also has concerns with the regulations. He believes the specifications on which physicians can prescribe it are too vague and thinks there need to be specific qualifying conditions for the use of the drug.

“It needs to be treated like any other drugs that doctors prescribe,” Yen said.

Bancroft said, come Tuesday, his vote is still yes.

“There’s always going to be a reason to not vote it in, so it’s now or never,” he said.

In reference to the regulations they have concerns over, there are plans in the works to address them.

Bud Scott, the director of New Health Solutions of Oklahoma, which funds the ‘Yes on 788 Campaign,’ said the organization has prepared more than 300 pages of proposed regulations if the state question passes.

Governor Fallin also said she expects to call lawmakers back for a special session if it passes.

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