3 posts tagged “drug development”

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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The lowdown on generic MS medications

Posted 7 months ago by

From FDA approvals to availability and safety, generic drugs are a popular topic in the PatientsLikeMe MS forum (more than 15 threads!). To help you stay in the loop about what generics are and what’s out there for MS, we checked in with our team of in-house health professionals. Here’s the scoop…

Let’s start with the basics: What are generic drugs?

According to the FDA, “a generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.”

So what sets the brand-name versions apart?

Generic and brand-name medications work the same way and provide the same clinical benefit. Generic medications have the same active ingredients as brand-name medications, but generics only become available after the patent expires on a first-of-its-kind (brand name) drug.

Coming soon:

  • Ampyra (dalfampridine), the only FDA-approved drug indicated to improve walking in adults with MS, is anticipated to have generic versions available sometime in summer 2018.

Currently available MS generic drugs:

  • Glatopa: Glatopa 40 mg/mL is an FDA-approved generic version of Copaxone 40 mg/mL for patients with relapsing forms of MS. Glatopa has been determined by the FDA to be therapeutically equivalent to three times-a-week Copaxone, and is a fully-substitutable medication. Glatopa is available by prescription.
  • Glatiramer acetate: 20 mg/mL (daily) and glatiramer acetate 40 mg/mL (3x weekly). These two FDA-approved injections are also generic versions of Copaxone, and can be expected to be as safe and clinically effective. Both are available by prescription.

On the horizon:

  • Gilenya‘s patent is set to expire in 2019, opening up the path to generic versions soon after.

Want to learn more about what members are saying about their experiences with generic MS medications? Join the conversation on PatientsLikeMe.

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