130 posts in the category “Epilepsy”

Epidiolex: First FDA-approved drug made from cannabis component (CBD)

Posted 2 months ago by

In a historic move, the U.S. Food and Drug Administration (FDA) recently approved Epidiolex — an epilepsy medication made from purified cannabidiol (CBD), found in cannabis. Read all about it and what it could mean for the future of cannabis-based treatments. As background, see these other recent write-ups we’ve done on medical cannabis/marijuana and CBD.

What is Epidiolex?

Epidiolex “is a liquid formulation of pure plant-derived cannabidiol as a treatment for various orphan pediatric epilepsy syndromes,” according to GW Pharmaceuticals, the U.K.-based company that markets the medication (an oral solution).

Some other info to keep in mind:

  • Limited scope of approval — The FDA approved the treatment specifically for two rare and severe forms of child-onset epilepsy — Lennox-Gastaut syndrome and Dravet syndrome — in patients 2 years of age and older.
  • No THC — Epidiolex is made from purified CBD and does not contain tetrahydrocannabinol (THC), the component of marijuana that causes a euphoric “high.”
  • Thorough research — Researchers studied the treatment’s effectiveness in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients. Epidiolex (taken along with other medications) helped reduce the frequency of seizures when compared with a placebo. Research also found the medication has a very low potential for abuse.
  • Side effects — The FDA says the most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.
  • Cannabis and CBD still controlled substances — Despite the approval of Epidiolex, other CBD and cannabis products are still currently (July 2018) “Schedule I” controlled substances under federal law, the FDA says (again, check out our CBD report for more info on laws and other FAQs).

Some reports say that Epidiolex could be prescribed for off-label uses (for patients with other forms of epilepsy), and its approval could open the door for other cannabis-based treatments

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” says FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to this kind of careful scientific research and drug development.”

GW Pharmaceuticals lists other possible treatments they’re studying or developing. GW also markets Sativex (nabiximols) in several other countries to treat cancer pain and multiple sclerosis spasticity, Forbes reports, and a U.S. phase 3 trial is planned to test Sativex for MS spasticity.

What’s your reaction to the approval of Epidiolex? Join PatientsLikeMe or log in to discuss Epidiolex and CBD with others in the forum, and explore treatments members have tried.

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Cannabidiol (CBD) oil and product FAQs: Fad or effective? Legal or not?

Posted 4 months ago by

Trending: Cannabidiol (CBD) oil, gummies, tinctures and more. Why are cannabis products gaining popularity as medical treatments and in general? As more states have legalized medical marijuana, more people have shifted their views on cannabis treatments (like former Speaker of the House John Boehner’s recent change of heart). And last month, an advisory panel at the U.S. Food and Drug Administration (FDA) unanimously recommended a medication made from CBD for some forms of epilepsy.

CBD comes from cannabis/marijuana but has some key differences. So, let’s take a closer look at CBD products and some FAQs, like, do they work and are they legal?

What is CBD?

Short answer: Cannabidiol (pronounced canna-bid-EYE-ol) or CBD is a chemical found in cannabis plants that does not produce a “high.”

More info: Cannabis plants can produce more than 100 different types of cannabinoids, a type of chemical that reacts with receptors in the brain. The two most common cannabinoids found in medical marijuana are THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol). THC is responsible for producing the mental and physical effects of medical marijuana. CBD has many of the same therapeutic qualities as THC, but without psychoactive effects. (For even more info, read our report called “Weed 101: How and why patients use medical marijuana.”)

Products made purely from CBD (without THC) do not produce the psychoactive high of other medical marijuana or some CBD/THC combination products. But, as a JAMA report and some in the medical cannabis industry have pointed out, many CBD products sold online are not accurately labeled (containing much more or less CBD than the label claims, or even containing some THC when it’s not mentioned on the label).

CBD is not regulated or approved by the FDA — but they have issued warning letters to some CBD producers with misleading labels.

Many doctors (in the U.S. and internationally) are hesitant to recommend smoking cannabis or inhaling any burned plant material but may be more open to CBD products that are not smoked. (Has your doctor or provider weighed in about medical cannabis or CBD products? Make a comment below.) You can buy CBD products online on sites such as neotericnutra.com. CBD products can be pretty expensive so search around for things like discounted CBD vape juice. You’ll find some great deals! I often buy my wholesale vape supplies online or in a store near me.

Are CBD products effective?

On PatientsLikeMe, members have reported trying CBD for about 160 different reasons, including specific conditions (ALS, Parkinson’s disease, epilepsy and fibromyalgia — to name a few) and symptoms (from anxious or depressed mood to stiffness/spasticity). Below is a list of CBD or cannabis products members have reported as treatments on the site — remember to discuss your treatments with your healthcare provider, and keep in mind that treatment responses vary:

Join PatientsLikeMe to see more details through the links above and to connect with other members about their treatment experiences.

Note: CBD industry insiders advise avoiding splashy websites that offer a “free trial” of the product — by filling out a form, you may be signing up for an unwanted subscription.

Is CBD legal?

Short answer: CBD is legal under some state laws but not under federal law — so it’s pretty confusing (even to healthcare providers).

More info: As of May 2018, there are 17 states with laws specifically about legal CBD. Most state laws allowing some CBD use tend to be very specific (for example, limiting a CBD product’s THC content) and are not the same as state medical marijuana laws.

Under federal law, cannabis products (including CBD) are illegal and classified the same as marijuana (and heroin and ecstasy) as a Schedule I controlled substance. The U.S. Drug Enforcement Agency (DEA) made headlines in Indiana (where some CBD is legal) a few months back when DEA spokesman Rusty Payne told the local news that CBD is illegal under federal law, but is not the DEA’s main focus. “We are in the middle of an opioid crisis in this country,” Payne said. “That’s our biggest priority right now. People are not dying from CBD. Some would argue lives are being saved by CBD. Are we going to get in the middle of that? Probably not.”

Last year, U.S. Rep. Morgan Griffith introduced a bill called the “Compassionate Access Act” to encourage the federal government to remove marijuana from “Schedule I” classification, exclude CBD from the definition of marijuana in order to allow better medical access, and regulate CBD products to ensure they’re low in THC. So far, the bill has only bounced around to various congressional subcommittees.

Have any questions, comments or feedback on CBD products? Make a comment below or — even better — become a PatientsLikeMe member to discuss this topic in the forum and see more treatment evaluations from people living with your condition.

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