Sativex ~ Investigational Cannabis

[drtarzanmd]

Sativex -

Investigational Cannabis-Based Treatment for Pain and Multiple Sclerosis

 

Developed by GW Pharmaceuticals, Sativex is a whole plant

medicinal cannabis extract indicated for the relief of

multiple sclerosis (MS) symptoms and the treatment of

severe neuropathic-related cancer pain.

 

Bayer has secured exclusive rights to market Sativex in the UK,

and has the option to extend this to other countries in Europe

and countries such as Canada. In December 2005, GW Pharmaceuticals

entered into an agreement with Almirall Prodesfarma,

under which Almirall can market Sativex throughout Europe,

except in the UK.

 

Sativex received regulatory approval for treatment of

neuropathic pain associated with MS in Canada in 2005.

In August 2007, Canadian regulators approved Sativex as adjunctive

analgesic treatment in adult patients with advanced cancer pain.

Sativex and a related tetrahydrocannabinol (THC) medicine have been

investigated in Phase II/III trials for the relief of cancer pain,

an indication for which Bayer also has the option to market the drugs.

 

In February 2007, GW Pharmaceuticals entered into a long-term

research and development alliance on medicinal cannabinoids

with Otsuka Pharmaceutical, which gave Otsuka exclusive rights to

develop and market Sativex in the US. The companies will jointly

oversee clinical development and regulatory activities in the US.

 

Having secured FDA approval to conduct trials of Sativex in patients

with advanced cancer, whose pain is unrelieved by opioids,

the companies are conducting the first US efficacy trial of Sativex

in neuropathic-related cancer pain, having begun in 2007.

The clinical spray trial of Sativex on a large number of cancer patients

(Phase II/III) is underway in the US and results are expected in 2010.

 

In July 2009, GW Pharmaceuticals received a licence for its new

in-house Sativex manufacturing facility after passing a good

manufacturing practice inspection by the UK regulatory authorities.

 

The company used to sub-contract the manufacturing of Sativex.

The facility, which has capacity to provide Sativex for 25,000 patients annually,

will be used to produce the drug for the European commercial launch.

GW Pharmaceuticals expects to increase capacity in line with demand.

 

In June 2010, GW Pharmaceuticals announced that Sativex had been

approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

The company subsequently launched the drug in the market.

GW Pharmaceuticals will receive £10m milestone payment from Bayer following the approval.

 

GW Pharmaceuticals is expecting approval of Sativex in Spain,

which will provide the company with £2.5m milestone payment from Almirall.

GW Pharmaceuticals is planning to file for regulatory submissions in

other European countries in the second half of 2010.

 

Cannabis-based medicines

 

Estimates suggest that 10-30% of MS patients in Europe smoke cannabis

to ease the pain and disabling symptoms of the disease.

This activity is illegal and patients run the risk of prosecution.

In the UK, cannabis-based medicines were outlawed in 1968, after

legislation banned doctors from prescribing tincture of cannabis.

This preparation contained high concentrations of the active THC

psychotropic ingredient and was popular among recreational cannabis users.

 

The UK Government gave GW Pharmaceuticals special permission

to investigate medicines derived from cannabis. This represents a major step

forward for MS patients, as for the first time they would have access

to safe and effective cannabis-derived drugs on prescription.

 

Sativex is a cannabis extract containing tetranabinex and nabidiolex

(cannabidiol – CBD) as its principal component.

It does not contain the active substance found in recreational cannabis

and so patients taking Sativex will not become intoxicated.

 

Sativex is not smoked, but administered by means of a spray into the mouth.

A 100µl dose of Sativex spray contains 2.5mg CBD and 2.7mg THC.

To meet demands for this innovative drug, GW Pharmaceuticals has

increased production of cannabis at its fortified greenhouses to 60t per year.

 

Clinical trials on Sativex point to efficacy and safety

 

Phase III placebo-controlled trials in about 350 patients with MS have

shown that administration of Sativex as a sublingual spray is a safe

and effective treatment for symptom relief. Compared with placebo,

significantly more patients in the Sativex treatment arm experienced

reduced neuropathic pain, spasticity and sleep disturbances.

 

Further Phase III data on 189 MS patients supports earlier registration trial data.

Again, treatment with Sativex produced a statistically significant

improvement over placebo in spasticity, the primary endpoint, (p<0.05).

 

Other secondary endpoints, such as the Ashworth scale,

also favoured Sativex over placebo. Overall, the data showed that Sativex

produced treatment effects over and above those achieved with existing medications,

which patients were allowed to continue while taking part in the Sativex trial.

 

Additional trials have been conducted to assess the effectiveness of

Sativex in treating neuropathic pain and spinal cord injury.

Results from three Phase III trials in patients with neuropathic pain

showed that the addition of Sativex to standard therapy produced improvements

over and above those obtained with existing medication.

Patients in these trials had all failed to response to standard therapy

and constituted a population with high clinical need.

 

GW Pharmaceuticals has also announced positive results of a

Sativex Phase III MS study in 573 UK patients with spasticity.

 

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.

 

Marketing commentary

 

In Europe alone there are some 500,000 MS patients on top of the four

million experiencing neuropathic pain. This fact, together with a market

poorly served by currently available drugs, presents an excellent

opportunity for Sativex if the encouraging results seen in multiple sclerosis

are reproduced in other patient groups.

 

Copy and Paste from :

 

http://www.drugdevelopment-technology.com/projects/sativex/

 

 

Also More Information on this Subject here :

 

Marijuana Prescriptions Soon To Be Available Through Sativex

 

https://www.marijuanadoctors.com/blog/general/marijuana-prescriptions-soon-to-be-available-through-sativex

[rafaeltoral]

It is interesting that GW Pharm tries to pass Sativex off as a whole-plant botanical based medication. Yet they list the primary active ingredients as CBD, and THC, only 2 of many cannibinoids found in whole cannabis.

 

The Pharmaceutical Industry likely will never produce a true whole-plant botanical based cannabinoid medicine. How could they patent such a thing and secure intellectual property rights? If such a thing were to be produced it would be very similar to simpson oil. I want the best of both worlds.

[Southern Cross]

These two paragraphs crack me up,

"Sativex is a cannabis extract containing tetranabinex and nabidiolex

(cannabidiol – CBD) as its principal component.

It does not contain the active substance found in recreational cannabis

and so patients taking Sativex will not become intoxicated.

Sativex is not smoked, but administered by means of a spray into the mouth.

A 100µl dose of Sativex spray contains 2.5mg CBD and 2.7mg THC.

To meet demands for this innovative drug, GW Pharmaceuticals has

increased production of cannabis at its fortified greenhouses to 60t per year."

 

So the active ingredients in a dose are about 50% THC and 50% CBD, but it does not contain the active substance found in recreational cannabis?

 

This is from a fact sheet on the Health Canada web site.

 

"What do patients need to know about using SATIVEX®?

SATIVEX® causes irritations in the mouth in 20 – 25% patients in clinical trials. Patients may also experience symptoms of cannabinoid intoxication, including dizziness when they first take SATIVEX®. Fainting episodes have been reported as well as feeling drunk, disturbance in attention, dizziness, somnolence, disorientation, dissociation and euphoric mood. THC can cause symptoms such as changes of mood, decrease in cognitive performances and memory, decrease in ability to control drives and impulses, and alteration of the perception of reality, particularly altered time sense. Patients should start from low doses and adjust their doses gradually to get the optimal balance of a good control on their neuropathic pain and minimal intoxication.

SATIVEX® may impair ability to carry out complicated tasks. Patients should not drive or engage in activities requiring unimpaired judgment and coordination.

Some drugs are broken down in the liver by the same route as SATIVEX®, so patients must inform their physician if they are taking other drugs.

 

What are the side effects and how serious are they?

Side effects are mild to moderate and mainly consist of either application site reactions in the mouth (such as dry mouth, stinging) or intoxication (such as dizziness, disorientation or impaired memory). There may be sickness or diarrhoea.

Patients should report all new symptoms after beginning using SATIVEX® to their doctor. Not all new symptoms are caused by SATIVEX®, but SATIVEX® may be responsible for some new symptoms."

http://scamparoo.wordpress.com/2008/06/17/sativex-fact-sheet-from-health-canada/