10 posts from July, 2018

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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Zoodles! Let’s dish on lupus/food + swap recipes

Posted 2 months ago by

If you’re living with lupus, have you found any particular foods that affect you and your condition — for better or worse?

Member Jeanette (JeanetteA6872), a member of the 2018 Team of Advisors who’s living with systemic lupus erythematosus (SLE), shares which ingredients she tries to include or avoid in her diet, plus three of her favorite recipes (psst—one involves zoodles!).

Food Q&A with Jeanette

Jeanette says she turned to dietary changes when she stopped taking Plaquenil due to severe side effects, including retina damage. “I had nothing to lose — I signed up for Tony Robbins’ Unleash the Power Within [a self-help program] that made me look at myself and my relationship with food differently,” she says. “I started logging my food intake for a few weeks on and off, I noticed how some of my favorite foods were causing me some issues ranging from stomach pains to full inflammation. That’s when I started paying close attention to what my body was telling me and I needed to do something about it.”

Here’s what else she shared with us in a recent Q&A. Everyone is different, so these foods and dietary changes may not affect you and your lupus the same way. Talk with your doctor or a registered dietitian about finding foods that work for you.

Have you noticed any specific ways that your diet or certain foods affect your symptoms?

I didn’t go on any specific diet at first, I started eliminating certain foods like sugar (which was causing major fatigue and pain), garlic (causing major inflammation in my knees), eggplants (fatigue and pain in my feet), bean sprouts (stomachaches) and alfalfa (full inflammation and full flare) — some of the known foods that lupus patients shouldn’t eat [learn more at lupus.org].

Then I noticed how meat was causing me fatigue and I noticed inflammation directly in my knees. I tried giving up red meat for two weeks, and I felt good and noticed a reduction of pain. Then I gave up chicken the following two weeks and felt even better. It was so amazing that I decided to give it up for good. After the first few months without meat, my doctor started noticing my blood work was improving drastically, so she began reducing my medications since I was no longer flaring or feeling pain. After a full year she reduced all of my medications to zero and even stopped my infusion.

I notice that if I eat too many potatoes like French fries, baked potatoes or mashed potatoes, as well as tomatoes, salsa, mushrooms and peppers, ice cream and cheese, I feel a little stiffness, so I know it’s too much. I really try to avoid processed and fried foods in general as I immediately notice stiffness.

I do still eat gluten and dairy products, just not every day. Everything in moderation works best, I’ve noticed. If something bothers me this week, I know not to repeat it.

Are there any foods that you try to eat often?

I don’t eat many of the same foods daily. I drink my shakes, but I like a variety of foods from pastas, salads, homemade cauliflower crust pizza, rice and beans, and I started eating fish again, so that’s more protein. There are meat substitutes like Gardein, Beyond Meat and black bean burgers that make great meals.

With the new eating style, I knew I needed to find some type of supplement for my vitamins and minerals because you get so many different vitamins from animal products and I wasn’t eating the same way as before. I tried Herbal Life, then Shakeology, then Modere, and none agreed with me because I have so many allergies. So I gave Isagenix one last try. It was perfect for me. Wow — my blood work started coming back so good, my doctor asked me what my secret was, since I [also] started working out and feeling even more amazing. I feel as if my life is back.

Do you have a few favorite recipes you’d like to share?

(Click on the links for a printable version of these recipes picked by Jeanette!)

Veggie scramble – This veggie-packed egg dish is scrambled in coconut oil and topped with avocado and tomato

Citrus fish tacos – Lettuce leaves serve as the “tacos” in this tilapia recipe, complete with mango salsa

Creamy zucchini pasta with shrimp – “Zoodles” (julienne-peeled zucchini “noodles”) and an avocado-basil “cream” sauce? Yum!

Which foods do you eat or avoid with your lupus in mind? Please add a comment below or join PatientsLikeMe to chime into this forum discussion!

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