drug development

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

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

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 by DailyCBD.com also found the medication has a very low potential for abuse. Side effects — The FDA says …

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The lowdown on generic MS medications

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 …

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From preclinical to approval: How clinical trials bring new treatments to market

Often we hear of new treatments becoming available, but have you ever wondered what each new treatment had to go through to get approved by a regulatory body like the FDA? Before a new treatment is approved for commercialization, it needs to go through a meticulous trial process to prove a number of things: Is the drug safe? What are the potential side effects? Does the drug do what it’s supposed to do? All of these questions and more need to be answered before a drug can be considered for approval by the FDA, so that’s where clinical trials come in. Here’s a breakdown of what’s involved in the drug development process, from preclinical through to commercialization and post-approval monitoring. (Click to enlarge) How can I participate in a clinical trial or find out more? You can learn more about research and clinical trials by joining or logging into PatientsLikeMe and clicking on the Research tab Use the PatientsLikeMe Clinical Trial Finder to search for trials that could be a good fit for you Check in with local associations and hospitals to see if they are recruiting for any trials Talk to your healthcare provider/clinician to see if there are opportunities …

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