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CBD News Roundup: FDA Approves Application for New CBD Therapy

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Written by The CBD Insider

Here’s the latest CBD news:

  • CardiolRX, a CBD-based drug developed to help with heart problems with or without COVID-19 complications, has had their Investigational New Drug application (IND) approved by the FDA.
  • Epidiolex has been approved by the FDA to treat a third condition characterized by seizures called tuberous sclerosis complex (TSC). 
  • Clinical oncologists surveyed 100 cancer patients, and most of them had neither tried CBD nor knew much about it.

FDA Approves Investigational New Drug Application for CBD-Based Therapy

Biotech developer Cardiol Therapeutics has been authorized by the FDA to conduct a placebo-controlled trial testing a CBD-based drug meant for myocarditis and other heart issues.

The approval of the Investigational New Drug application (IND) by the FDA provides Cardiol a pathway to clinically test and, if results are favorable, continue with product development and eventual distribution of CardiolRX, the CBD-based drug.

Myocarditis, or inflammation of the heart muscle, has been linked with COVID-19 vaccinations, especially among younger populations.

Moreover, patients who already had coronary vascular disease prior to contracting COVID-19 are at a greater risk for severe heart issues while fighting the virus, including heart attack, stroke, arrhythmias, and more.

The 100-participant trial to be conducted by Cardiol will closely examine the “cardioprotective” benefits—a suspected attribute of CBD—as delivered by CardiolRX.

Epidiolex Granted FDA Approval for Tuberous Sclerosis Complex

Already approved by the FDA to treat Lennox-Gastaut syndrome and Dravet syndromes, two severe forms of childhood epilepsy, CBD-based Epidiolex is now approved for the treatment of tuberous sclerosis complex (TSC).

TSC is a rare, complex genetic condition associated with the widespread proliferation of benign tumors, neuropsychiatric problems, and seizures, among other symptoms.

As we reported back in January, the Journal of the American Medical Association (JAMA) published a study in December of 2020 in which an oral cannabidiol solution decreased seizure frequency by 30.1% among TSC sufferers.

Per the FDA’s approval notice, the most common side effects reported by TSC patients taking Epidiolex in the clinical trial included diarrhea, elevated liver enzymes, reduced appetite, and sleepiness.

Survey Shows High Public Interest, Limited Understanding of CBD

A study published in the Clinical Journal of Oncology Nursing confirms what the FDA and many physicians have been parroting for years now: CBD is popular, but we still don’t know enough about it.

The study designers, which included nurse practitioners, an oncologist, and oncology pharmacy professionals, created a survey intended to gauge the collective understanding of CBD among current or former cancer patients.

The survey, which was administered to 100 patients, asked about their use of complementary or alternative treatments, the effects of said treatments on cancer symptoms, and more.

Though an overwhelming 85 percent of participants reported using alternative treatments, the majority of participants had yet to try CBD.

Tellingly, this majority listed “lack of knowledge about CBD” and “providers not recommending CBD” as justification for not trying it.