By Alfa · Feb 8, 2005 ·
  1. Alfa

    Mouth Spray Wins Preliminary Approval

    U.K. and U.S. Tests Loom

    As some popular painkillers come under fire for causing dangerous side
    effects, an often-shunned alternative is gaining legitimacy in pain relief:

    Medical marijuana has been winning legal endorsement through the efforts of
    a British pharmaceutical firm. GW Pharmaceuticals of Salisbury, England,
    has spent years developing and promoting a cannabis-based mouth spray that
    the company claims eases severe pain and muscle stiffness without causing a
    psychotropic high. Winning the backing of health authorities has been an
    uphill battle, but Canadian officials recently gave it preliminary approval
    for treatment of neuropathic pain in multiple sclerosis sufferers. Studies
    concluded not long ago also showed the product effective at treating severe
    cancer pain.

    Now GW is aiming for approval in the United Kingdom, and longer-term, in
    the U.S., where medical marijuana is likely to come up against greater
    resistance. "The deepness and polarity of the [marijuana] debate in the
    U.S. is unique," acknowledges Geoffrey Guy, executive chairman of GW. GW
    hopes the Canadian approval "will force the U.S. to address this issue once
    and for all and make a decision," says Managing Director Justin Gover. If
    the product is approved in more markets, GW believes it one day could be
    used by a million patients suffering from pain associated with MS, cancer
    and other ailments.

    The treatment, called Sativex, is an extract of a hybrid form of cannabis
    grown by GW. The company says the plants are specially bred to remove most
    of the psychotropic agents and to increase the presence of helpful
    properties such as cannabidiol. The company, which won a special license
    from the U.K. to breed cannabis and carry out research, grows 50,000 plants
    every year in greenhouses in a location it keeps secret so as to avoid
    curiosity seekers, protesters and potheads.

    Founded in 1998 to research the medicinal uses of cannabis, GW is traded on
    the London Stock Exchange. The company has a few other cannabis-derived
    products in early development.

    Richard Payne, a 56-year-old Briton with multiple sclerosis, began taking
    Sativex three years ago as part of a clinical trial and says the medicine
    helps relieve his muscle stiffness and gives him better bladder control. It
    also has alleviated the violent muscle spasms that used to keep him awake
    at night.

    Finding the Right Dosage

    "When I was finding a level that suited me I did get in an intoxicated
    state once," he says, but he's since decreased the dosage, as he believes
    most pain sufferers would. "If you took all your eight-week supply in a few
    days you'd probably be very high," he says. "But I think people who suffer
    MS would rather have a better quality of life for eight weeks than have a
    couple of days where you don't know what's going on in the world."

    In late December, Canada's health agency issued what it calls a "qualifying
    notice" for the approval of Sativex to treat neuropathic pain in MS
    patients. The de facto approval will become official once GW submits extra
    forms agreeing to certain conditions, including an obligation to carry out
    additional clinical trials with the product. GW says it expects its
    partner, Bayer AG, to begin marketing Sativex within a few months in
    Canada, where 50,000 people have MS.

    Canadians, who legalized smoked marijuana for those with "grave and
    debilitating illnesses" in 2001, have a fairly accepting attitude toward
    the cannabis plant. The fact that British officials gave GW permission to
    grow and test its product in Britain gives the company hope that it may win
    approval there, too, possibly as soon as this summer.

    The U.S. will be a harder sell. Under the classification system of the 1970
    Controlled Substances Act, marijuana is listed as having "no currently
    accepted medical use." That hasn't stopped gravely ill patients from
    smoking it on the sly, and in recent years 11 states have defied federal
    law by making marijuana legal for medicinal use. California was the first,
    passing its 1996 Compassionate Use Act after heavy lobbying by AIDS
    patients and others. Last year, Montana and Vermont became the latest
    states to pass similar laws.

    The Bush administration says the state laws interfere with federal efforts
    to combat illegal drugs and has sought to overturn them. In 2002, Federal
    Bureau of Investigation agents raided the home of a California woman who
    was growing marijuana to treat her lower-back pain. The woman and a
    colleague filed a lawsuit against the federal government, a case that has
    worked its way up to the Supreme Court. The court began hearing the case,
    Ashcroft v. Raich, last year, and is expected to rule in July.

    Doesn't Give a High

    GW hopes Sativex will avoid similar controversy because it isn't smoked
    and, when used properly, doesn't give a high. The company has spent several
    years explaining its product in meetings with key U.S. officials and says
    it hopes to open discussions with the Food and Drug Administration in the
    coming months. As a first step, GW is aiming to win FDA permission to carry
    out a clinical trial of Sativex on American patients.

    An FDA spokeswoman declined to comment on Sativex's prospects for approval.
    Last summer, Robert J. Meyer, a director of the FDA's office of drug
    evaluation, told a congressional committee that the FDA would "continue to
    be receptive to sound, scientifically based research into the medicinal
    uses of botanical marijuana and other cannabinoids" and would "facilitate
    the work of manufacturers interested in bringing to the market safe and
    effective products."

    Sativex's approval in Canada won't make the product easily available to
    Americans driving over the border. The medicine will be available only by
    prescription in Canada and will be illegal back in the U.S.

    Several years ago, the FDA approved a medicine called Marinol that is made
    from a synthetic copy of a compound found in cannabis. The medicine, sold
    by Solvay SA of Belgium, is used to treat appetite loss and weight loss in
    AIDS patients. Other drug companies also are working on synthetic compounds
    that mimic cannabis, including Indevus Pharmaceuticals, which is testing
    such a product in late-stage human trials. Because Sativex is made from
    pure cannabis extract, it will be a harder sell.

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