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Sativex（舌下喷剂）能减轻多发性硬化症的疼痛

2011-03-20 12:01:33 作者：新特药房来源：中国新特药网天津分站浏览次数：481 文字大小：【大】【中】【小】

简介： 舌下喷剂Sativex - Oromucosal为神经性疼痛，痉挛，膀胱过动症，癌症疼痛的多发性硬化症患者口腔喷雾 - 剂量 - 逐步增加，最高每天12喷剂，喷剂15分钟之间的差距 - 药物相互作用引起嗜睡 - 不适合 ...

关键字：Sativex 舌下喷剂多发性硬化症疼痛

舌下喷剂Sativex

- Oromucosal为神经性疼痛，痉挛，膀胱过动症，癌症疼痛的多发性硬化症患者口腔喷雾

- 剂量 - 逐步增加，最高每天12喷剂，喷剂15分钟之间的差距
- 药物相互作用引起嗜睡
- 不适合于18岁以下使用

- 没有法律规定
- 存放在冰箱开幕之前，一旦打开就可以了。

4 ×5.5毫升是旧的和无牌包装大小，目前的包装规格为3 × 10毫升，必须与相应的处方确定

Sativex - Based Treatment for Pain
What is Sativex?

Sativex is the world's first prescription medicine derived from the cannabis plant. The medicine is standardized by both composition and dose and is being developed for the treatment of conditions such as spasticity in multiple sclerosis, cancer pain, and neuropathic pain of various origins.

Sativex is administered as an oral spray which is absorbed by the patient's mouth. Sativex contains active ingredients called 'cannabinoids', which are extracted from cannabis plants grown and processed under strictly controlled conditions. It is composed primarily of a 1:1 ratio of two cannabinoids-CBD (cannabidiol-a non-psychoactive cannabinoid) and THC (delta-9-tetrahydrocannabinol). The CBD:THC formulation is believed to enhance the therapeutic benefits of THC while modulating the unwanted psychotropic and other THC-related side effects, such as tachycardia. The spray delivery system keeps THC from entering the blood too rapidly and also minimizes the development of unwanted psychotropic effects.

How does Sativex work?

Cannabinoids react with cannabinoid receptors that occur naturally throughout our bodies, including in our brains. A receptor is a site on a brain cell where certain substances can stick or "bind" for a while. If this happens, it has an effect on the cell and the nerve impulses it produces, which causes a 'dimming down' of the symptoms of spasticity. In patients who respond to Sativex, it is this effect which helps to improve their symptoms of spasticity and to help them cope better with their usual daily activities.

Main effects of CBD:

Anti-inflammatory
anticonvulsant
antipsycotic
anti-oxidant
neuroprotective
immunomodulatory

Main effects of THC:

Analgesic
anti-spasmodic
anti-tremor
anti-inflammatory
appetite stimulant
anti-emetic

Treatment of Severe Neuropathic Pain

Neuropathic pain, which is frequently chronic, arises when neurones in the brain or peripheral nervous system become hypersensitised and generate abnormal or prolonged impulses. There are many causes of neuropathic pain, including diabetic neuropathy, post-herpetic neuralgia, fibromyalgia, multiple sclerosis and cancer. Around 40% of cancer patients suffer some degree of neuropathic pain.

Severe neuropathic pain has proved difficult to treat and evidence suggests that no available drug is effective in more than 50% of patients. Thus, it represents an area of significant unmet clinical need.

The encouraging data from the Sativex Phase III registration trials in multiple sclerosis patients suggest cannabis-derived medicines may have a valuable place in this sector of the pain market.

What side effects does Sativex have?

GW's clinical trials have generated over 1300 patient-years of safety data, and adverse events have been predictable and generally well tolerated. The most common side effects of Sativex are dizziness, which occurs mainly in the first few weeks of treatment, and fatigue. These reactions are usually mild to moderate and improve within a few days even if treatment is continued. These side effects are common to many other prescription medications, particularly pain medications.

Where is Sativex available?

In the UK, Sativex has just been approved and launched as a prescription medicine as a treatment for spasticity due to multiple sclerosis.

In Canada, Sativex is approved under Health Canada's Notice of Compliance with Conditions (NOC/c) policy for the relief of neuropathic pain and advanced cancer pain.

In Spain, Sativex is expected to be approved shortly and launched in H2 2010. Further submissions will be made to additional European countries in H2 2010 under the mutual recognition procedure and we anticipate approvals in other European countries in H1 2011. In certain other countries, Sativex is available on prescription on a named patient basis. In total, Sativex has been exported to 28 countries either for named patient prescription use or for clinical trials purposes.

In the US, Sativex is an investigational drug being developed as an adjunctive (additive) analgesic treatment for patients with advanced cancer whose persistent pain has not been adequately relieved by optimized treatment with strong opioids. The FDA has not approved Sativex and the product is not available in the United States other than for use in FDA approved clinical trials.
Sativex~能减轻多发性硬化症病人的疼痛
一项有66例多发性硬化症(MS)患者参加的随机、安慰剂对照的临床试验,评价大麻属植物药Sativex~对MS患者疼痛的效果。