New Zealand medicines regulators have approved a cannabis-based spray for use by multiple sclerosis (MS) patients in this country, says a big manufacturer, GW Pharmaceuticals.
Its Sativex treatment for the relief of spasticity in MS patients contains two cannabinoids or active ingredients - THC and CBD, and is the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant.
New Zealand's was the fourth approval for Sativex following positive decisions in the UK, Spain and Canada, GW research director Stephen Wright said in a statement.
"We are delighted that Sativex has received positive endorsement from another of the world's most highly regarded regulatory authorities".
Medsafe spent nearly two years considering whether to allow the marketing and sale of the cannabis spray. The government faced increasing pressure from some patients and scientists to legalise cannabis use to alleviate chronic pain for accident victims, and some sufferers of multiple sclerosis and cancer.
Cannabis is a class C drug and cannabis preparations are class B drugs, but the Medicines Act allows the drug to be used with ministerial approval.
In 2008, the Health Ministry said approval to use Sativex had been granted for three patients, and a further application was pending.
Criteria for the trial said patients had to have either nausea, anorexia and wasting associated to cancer and Aids, or chronic pain for which other pain relief treatments were unsuited, neuropathic pain associated with MS, stroke, cancer, spinal cord injury, severe physical trauma or peripheral neuropathy resulting from diabetes, or muscle spasm and spasticity associated with MS or spinal cord injuries.
The spray is administered under the tongue and has been legal in Canada since 2005.
In a briefing paper to the previous Labour government, officials said there was "sufficient evidence of safety and efficacy of cannabis in some medical conditions" to support consideration of compassionate, controlled use.
One lobbyist, Billy McKee, complained that patients who used cannabis medicinally faced many risks in buying it on the black market.
He smoked cannabis to control chronic nerve pain dating from car crash injuries sustained 15 years ago and said he would welcome Sativex if he could "easily access and afford it". But he believed users could face costs of $150 to $300 weekly if it was not subsidised by Pharmac.
McKee said users faced obstacles growing their own, illicit, drug: his home had been burgled 20 times by thieves trying to remove plants.
According to an Otago University pharmacology professor Paul Smith, the THC and cannabidiol in the spray will not work for all chronic pain sufferers but initial results in multiple sclerosis patients showed about 30 percent success, including reducing symptoms in some patients.
In its application to Medsafe, GW Pharmaceuticals said that in therapeutic doses, Sativex may produce side-effects "interpreted as a euphoria or cannabis-like high".
Friday, November 5, 2010
Posted by BA Haller at 4:56 PM