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  1. Beenthere2Hippie
    GW Pharmaceuticals continued its streak of good luck. The London-based drugmaker posted another set of positive phase 3 data for Epidiolex, an experimental cannabis drug being used to treat seizures in a rare form of epilepsy called Lennox-Gaustaut Syndrome (LGS).

    Different doses yielded different results, according to GW’s announcement. A 20-mg dosage of the drug taken daily contributed to a 42 percent drop in monthly seizures compared to 17 percent for participants taking placebo. Volunteers taking 10mg a day experienced an estimated 37 percent monthly drop in seizures while the placebo portion of this group stayed at 17 percent.

    Common adverse events varied between diarrhea and upper respiratory infections, but the pattern remained consistent with previous trials. Overall, the drug was generally well tolerated.

    This new data bodes well for GW, reported Reuters.

    A trove of positive data like this could help the 18-year-old firm support its case for regulatory approval potentially making Epidiolex the first U.S. approved prescription drug extracted from cannabis.

    The U.S. Food and Drug Administration has already granted Epidiolex an orphan drug designation for LGS and a similar disorder called Dravet syndrome giving GW a formidable therapeutic candidate in a market that is just starting to develop.

    A marketing application is expected to be submitted to the FDA in the first half of next year.



    By Ryan Bushey - Drug Discovery & Development/Sept. 27, 2016
    http://www.dddmag.com/article/2016/09/gw-pharma-publishes-more-positive-data-cannabis-drug
    Newshawk Crew

    Author Bio

    Beenthere2Hippie
    BT2H is a retired news editor and writer from the NYC area who, for health reasons, retired to a southern US state early, and where BT2H continues to write and to post drug-related news to DF.

Comments

  1. scartissue_68
    Re: Epidiolex, GW Pharma's New Cannabis Drug for Rare Seizures, Set for Marketing Pha

    The article doesn't specify how cannabis is processed to be used in this drug, so let's assume its made from organic cannabis or natural extracts. If approved by the FDA, this product would probably be put into Schedule II. It could then be argued this would make cannabis legal for the entire US. The precedent would be set. That seems good, but consider the unintended consequences:

    The drug Sativex, which is also prepared from natural cannabis (legal in many countries for the treatment of epilepsy) has already been "shot down" by the US FDA. Some say it was because the US drug company sponsoring the drug went too far in it attempt to get is "indicated " to include cancer pain. Conspiracy theories sight the conflict that would exist between the Controlled Substance Act and FDA approval for prescription use of Sativex.

    I have stated before and repeat now, "I prefer that cannabis simply be removed from the category of a controlled substance", as is alcohol. We really don't want the FDA deciding which strains are "good for us" and which are "too good for us".

    If natural cannabis (in any form) becomes a Scheduled II Controlled Substance, its cost will skyrocket because a weed will become a proprietary drug, direct to consumer sales would be eliminated....and a trip to a doctor necessary to get it prescribed.
  2. aemetha
    Re: Epidiolex, GW Pharma's New Cannabis Drug for Rare Seizures, Set for Marketing Pha

    I wondered about the same thing actually scartissue.

    Having cannabis rescheduled also doesn't solve many of the health issues currently surrounding cannabis use, specifically keeping it from causing the disproportionate harm it has been shown to do to young people in numerous studies. Because it's all illegal (and the law is basically ignored by large sections of the community) it's impossible to target regulations at keeping it from people most at risk of harm from it (those with developing brains). Taxing and regulating it frees up money from law enforcement to be reallocated to harm reduction in addition to the money earned through taxation.
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