better late than never
http://ekstrabladet.dk/kup/sundhed/article1568269.ece
http://ekstrabladet.dk/kup/sundhed/article1568269.ece
http://en.wikipedia.org/wiki/SativexMore marijuana medicine to the sick
Sclerosis Patients can now get a mouth spray with cannabis to relieve their spasms. It has the Interior and Health Minister Haarder (V) decided
16:31, 08 June 2011 | Anders Borup Sørensen
Mouth spray Sativex will among other things made of extracts from the cannabis plant. It is only approved for multiple sclerosis patients.
It has long been known that marijuana can help sclerosis difficulty to relax when they get their bouts of muscle cramps. But now do the patients no longer go on Christiania to enjoy a soothing joint
Interior and Health Minister Haarder (V) has changed the notice of narcotics to make room for cannabis products in the medicine market. First product on the shelf is Sativex. A mouth spray with cannabis for multiple sclerosis patients.
- I understand from Medicines Agency that Sativex can help patients with multiple sclerosis (the most common form of sclerosis ed.) That do not have the benefit of others sclerosis drugs. So we should not be rigid bureaucratic rules get in the way that this patient group may have a treatment that can help. Therefore I will now amend the notice of narcotics, as extracts of cannabis continue to be used for medical purposes, ie. accordance with a medical prescription, says Haarder (V).
A pure product
Before the new ordinance took effect may pharmaceutical products in Denmark does not include cannabis extract. Only if the Medical Products Agency made a specific author, it could be done.
In Medicines Agency has therefore been aware that patients sought against the illicit cannabis market for calming in the form of marijuana. It was not only therefore that Sativex was approved.
- It's a mix of new times and better documentation of the impact of cannabis products. But of course it is advisable that people get a drug instead of doing something criminal. Here they know what they get. They do this not out of town, says Steffen Thirstrup is Consultant in Medicines Agency approval.
Fear not abuse
Lawful pursuit of Sativex will not Medicines Agency to fear that it will be abused. They have tried to limit a possible overuse or misuse by making product copyright. This means that they can keep track of how much each doctor uses.
- Of course one must weigh the chances of abuse against the impact of the product. So here it must not harm patients. How it is also with morphine. It's street addicts also very interested in, "says Steffen Thirstrup.
Sativex is a cannabinoid mouth spray developed by the UK company GW Pharmaceuticals for multiple sclerosis patients, who can use it to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms. Sativex is also being developed in Phase III trials as a potential treatment to alleviate pain due to cancer. It has also been researched in various models of peripheral and central neuropathic pain. Sativex is distinct from all other pharmaceutically produced cannabinoids currently available because it is derived from cannabis plants, rather than a solely synthetic process. Sativex is a pharmaceutical product standardised in composition, formulation, and dose. Its principal active cannabinoid components are the cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD). The product is formulated as an oromucosal spray which is administered by spraying into the mouth. Each spray of Sativex delivers a fixed dose of 2.7 mg THC and 2.5 mg CBD.
In June 2010, the Medicines and Healthcare products Regulatory Agency of the United Kingdom licensed Sativex as a prescription-only medicine for the treatment of spasticity due to Multiple Sclerosis. This regulatory authorization represents the world's first full regulatory approval for the medicine. Sativex is being marketed in the UK by Bayer Schering Pharma. However, despite this approval, many MS patients are being denied Sativex due to local PCT resistance to its' funding .[4].
Sativex was also approved in Spain for MS spasticity in the second half of 2010 and was launched in that country in March 2011. Sativex was approved in the Czech Republic in April 2011, in Germany in May 2011 and in Denmark in June 2011. Sativex has also been recommended for approval in Italy, Sweden and Austria with formal approvals expected in these countries during 2011. In Spain and other European markets (excluding the UK), Sativex will be marketed by Almirall.
In Canada, Sativex has been approved by Health Canada for the treatment of MS spasticity. It has also received a licence with conditions (NOC/c) for two additional uses: [5] as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis,[5] and also for pain due to cancer.[5][6]
Sativex is available in a number of countries as an unlicensed medicine, which enables doctors to prescribe the product to individual patients who they consider may benefit. The product has been exported from the UK to a total of 28 countries to date.
In February 2007, GW and Otsuka Pharmaceutical announced an exclusive agreement for Otsuka to develop and market Sativex in the United States. The first large scale US Phase IIb trial, Spray Trial, for cancer patients reported positive results in March 2010. GW and Otsuka have now commenced the Phase III development of Sativex in cancer pain.
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