Tag: Epidiolex

  • Google to Allow Limited CBD Advertising in 3 Markets

    Google to Allow Limited CBD Advertising in 3 Markets

    Credit: NMann77

    In a sudden change of policy, Google will allow the advertising of hemp and topical CBD products in California, Colorado and Puerto Rico under an update to its policies on “Dangerous Products and Services and Healthcare and Medicines.”

    Google did not make clear why it is restricting the advertising to the three distinct markets, according to Hemp Today.

    Advertising for CBD for internal human consumption remains off limits, the company said, including those for “supplements, food additives, and inhalants.” Also, masthead advertising on YouTube (owned by Google), which appears at the top of the page in the main feed across all devices, is not available to hemp and CBD products, under the policy revisions.

    Google also said pharmaceuticals approved by under the Food and Drug Administration (FDA) may now also be advertised in those jurisdictions. That part of the rule change will benefit only one producer, Jazz Pharmaceuticals, whose high-CBD Epidiolex is the lone such product approved by the agency to date. Epidiolex is prescribed for severe seizure disorders in children. It was approved by the FDA in 2020.

    The changes take effect Jan. 20. Advertisers can request certification with Google starting on that date, when an application form will be published.

    Google said it has contracted with LegitScript, a Portland, Oregon-based internet and payments compliance company that provides certification in high-risk industries, as a clearinghouse to determine products’ advertising eligibility. Only products that pass muster with LegitScript can be promoted on Google platforms.

    Those seeking certification to advertise on Google must provide samples of their products or THC testing and provide LegitScript with third-party certificates of analysis, according to Google.

  • U.S. FDA Approves CBD Drug for New Seizure Treatment

    U.S. FDA Approves CBD Drug for New Seizure Treatment

    Epidolex
    Credit: GW Pharma

    The US Food and Drug Administration (FDA) has approved the cannabidiol (CBD) drug Epidiolex oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older, according to press release from GW Pharma.

    TSC is a rare genetic disease that causes non-cancerous tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC affects about 1 in 6,000 people, according to the release.

    Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

    Epidiolex’s effectiveness for TSC-associated seizures was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of 224 received Epidiolex. Patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the 16-week treatment period than patients who received placebo.

    The most common side effects in Epidiolex-treated patients were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. The FDA had granted Priority Review designation for this application.