The results of a Phase III trial have shown the ability of GW Pharmaceuticals’ cannabinoid based medicine Sativex to reduce severe spasticity associated with Multiple Sclerosis.
According to the data, published in the European Journal of Neurology, about half of MS patients who had failed to respond to standard therapy experienced an improvement in spasticity after taking Sativex Oromucosal Spray (delta-9-tetrahydrocannabinol and cannabidiol).

The trial hit its primary goal of demonstrating that Sativex induced a significant improvement in the scores of spasticity, spasm frequency and sleep disturbance related to spasticity compared to a placebo.

Following a four-week, single-blind therapeutic trial period involving 572 patients, Sativex was shown to have reduced the mean score for spasticity, with 48% of patients achieving a clinically meaningful improvement of =20% in spasticity severity.

Of these responders, 241 took part in a 12-week, randomised, placebo-controlled trial phase, at the end of which the number of patients reporting an improvement in spasticity scores of =30% was significantly greater in the Sativex group (74%) than in the control arm (51%).

“We have been aware for a long time that cannabinoid medicines can significantly improve spasticity, which is a common, complex symptom of MS, and now the results from this study prove the positive impact they can have on patients’ symptoms, and ultimately their lives,” said Professor John Zajicek, Honorary Consultant in Neurology, Derriford Hospital and Chair of Clinical Neurosciences at PCMD, University of Plymouth, commenting on the findings.

MS affects around 100,000 people in the UK, and spasticity is a common symptom that is considered to be a major cause of disability, interfering with many every day activities such as walking, picking up objects, washing or dressing.

Sativex was approved by health regulators in the UK and Spain last year, but only in patients who have not responded to other medication and who show a clinically significant improvement in symptoms during a trial run of therapy.

Overall, GW Pharma is celebrating a stellar year with 27 sales hike GW Pharma s cannabis-based MS drug approved in Spain GW rolls out cannabis-based MS drug Sativex in UK Sativex deemed approvable by regulators in UK Spain. GW Pharma’s share has also received a boost on initial Sativex research on reducing cancer pain data.

From: http://www.pharmatimes.com/Study_backs_use_of_cannabis-based_Sativex_to_treat_MS

Concerns over the link between rising skin cancer rates and exposure to sunshine may have led to overly precautionary advice being given to the public about staying out of the sun at midday, according to a confidential “position statement” by leading health organisations.
The current advice to the public from the leading research charity on skin cancer, Cancer Research UK, states to spend between 11am and 3pm in the shade and to cover the skin with clothing, hats and sunscreen if out.

But a confidential position statement being prepared by the charity in collaboration with other health organisations – and seen by The Independent – acknowledges the changing evidence and emphasises the importance of exposing the skin to the midday sun without any protection in order to maximise production of vitamin D.

Many experts are concerned that past advice designed to protect against skin cancer may have resulted in an increased risk of other illnesses linked to a lack of vitamin D, which the body can only produce when skin in exposed to bright sunlight.

New concerns about Britain’s policy on sun exposure led to this review of the evidence about the risks and benefits of staying in the shade and covering up during the sunniest part of the day.

The confidential document, seen by The Independent, says: “The time required to make sufficient vitamin D is typically short and less than the amount of time needed for skin to redden and burn. Regularly going outside for a matter of minutes around the middle of the day without sunscreen should be enough. When it comes to sun exposure, little and often is best.

“However, people should get to know their own skin to understand how long they can spend outside before risking sunburn under different conditions.”

The wording of the draft document is being seen by come commentators as a tacit admission by Cancer Research UK that it had got it wrong in the past about telling people to avoid the midday sun, to apply sunscreen and to stay in the shade in order to avoid exposure to the cancer-causing rays of the sun.

“Cancer Research UK is working on a new position statement on vitamin D and sunshine which it expects to agree with other health organisations,” said Oliver Gillie, a health writer who has championed the case for vitamin D. “Their new position is expected to break with 20 years of advice to seek the shade and is expected to suggest that people go out in the sun in the middle of the day for at least a few minutes. Several health bodies have agreed to the wording but others are still discussing the details.”

Organisations such as the British Heart Foundation, the Multiple Sclerosis Society, Diabetes UK and the National Osteoporosis Society are discussing what their public position should be on sunshine and vitamin D in the light of several new studies suggesting a link between various illnesses and a chronic lack of the vitamin.

The draft position statement says: “Cancer Research UK’s SunSmart campaign encourages people to enjoy the sun safely and avoid exposures that lead to sunburn. However, for most people, sunlight is also the most important source of vitamin D, which is essential for good bone health.

“It is important to ensure that skin cancer prevention messages are balanced with the need to make enough vitamin D, and reflect the latest scientific evidence.” Sara Hiom, director of health information at the charity, said that the draft consensus statement has not yet been finalised, agreed or released. “It is not our advice to the public and should not be interpreted in that way,” Ms Hiom said.

“Even once we reach a consensus we will not be advising the public to go in the sun in the middle of the day without sunscreen. This is because, for some people – those most likely to be at risk of skin cancer – a few minutes in the middle of the day is enough for them to burn and cause serious and lasting skin damage.

“The very fact that messages around safe sun exposure times cannot be generalised to the population means that our advice needs to be general and is, and will remain, to enjoy the sun safely, spend time in the shade around midday and know your own skin type.”

From:http://www.independent.co.uk/public-advice-on-suntanning-may-mean-vitamin-deficiency-risk

The first licensed medical drug containing whole cannabis plant extracts has been launched to treat symptoms of multiple sclerosis (MS).
Sativex will be made widely available after it was approved by the medicines regulator last week.

Taken as a mouth spray, it is used to help alleviate symptoms of spasticity – involuntary muscle stiffness and spasms – associated with MS and is said to be the first symptom relief drug specifically for those with the condition.

It is the first cannabinoid medicine derived from whole plant extracts of the cannabis sativa plant, and is only the second cannabinoid drug to be licensed by the Medicines and Health care products Regulatory Agency (MHRA).

Cannabis is a Class B drug and using it for medicinal purposes remains illegal in the UK.

But doctors can prescribe Sativex to MS patients experiencing the spasms and cramping associated with spasticity.

MS charities welcomed the regulator’s approval of the drug, which was developed by UK-based GW Pharmaceuticals.

Pam Macfarlane, chief executive of the MS Trust, described today’s launch as a milestone.

She said: “We have been aware for a long time, based on comments from people with MS, that cannabis-based medicines can significantly improve spasticity, which is a common, complex symptom of MS.

“For this reason, the MS Trust has campaigned for the availability of a licensed medicine that can be properly controlled and prescribed.”

She added: “The launch of Sativex is a milestone for the NHS and the MS Trust and we are delighted. It will now be down to specialist professionals to assess people and we hope that this can happen quickly.”

Ed Holloway, head of care and services research at the Multiple Sclerosis Society, said: “Sativex can help alleviate one of the most distressing symptoms of MS and its licensing is good news for people with progressive forms of the condition, for whom drugs and therapies are sparse.

“We’d like to see it made available to anybody who might benefit.”

Doctors have been able to prescribe the drug to named individuals at their own risk since 2006, the Home Office said.

About 2,000 people in the UK are already prescribed it on this basis but any MS patient will now be able to request a prescription for the drug from their doctor, meaning many more will be able to obtain it.

About 100,000 people in the UK have MS, a condition of the central nervous system.

It is most often diagnosed in those aged between 20 and 40, with women nearly twice as likely to develop it as men.

It can cause a wide range of symptoms besides spasticity, including fatigue, visual problems, cognitive problems and mood changes.

The only other MHRA-approved drug containing cannabinoid – a compound found in cannabis – is Nabilone, which was licensed in February 1995 for the treatment of nausea and vomiting suffered by cancer patients undergoing chemotherapy.

Unlike Sativex, the cannabinoid’s it contains are synthetic.

From: http://www.telegraph.co.uk/MS-sufferers-welcome-first-licensed-cannabis-based-drug