GW Announces Positive Preliminary Results with its Cannabis-based Medicine (Sativex®) in Phase III Cancer Pain Trial

19/01/2005

GW Pharmaceuticals announces positive preliminary results in a Phase III clinical trial with Sativex® in 177 patients with severe cancer pain.
The trial was a multi centre double-blind, randomised, placebo-controlled parallel group study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine). In addition to study medication, all patients remained on their existing opioid and other analgesic medication during the trial.

The study included two different study medications - Sativex (a cannabis medicine containing tetrahydrocannabinol (THC) and cannabidiol (CBD)) and a THC-rich extract. Patients entering this three arm study were randomised equally to one of Sativex, THC extract or placebo. Each of these study medications were administered by means of a spray into the mouth.

In this Phase III trial, Sativex achieved a statistically significant improvement in comparison to placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of the study. A responder analysis showed that approximately 40% of patients on Sativex showed a greater than 30% improvement in their pain (p=0.024).

Analysis of escape medication, a second primary endpoint, showed that there were no significant changes in the use of escape medication. The improvements seen in pain were therefore attributable to the positive effects of Sativex. = We knew that

The other active arm of this study, GW’s THC extract did not show a significant effect in pain (p=0.24). This trial therefore suggests that Sativex is the more effective product for use in cancer pain.

In the trial, the adverse event data showed the medicines to be generally well tolerated.

Approximately 40 per cent of cancer sufferers at present have unmet needs in pain suppression.

Dr Stephen Wright, GW’s R&D Director, said, “Patients in this trial were suffering intense pain as a result of their cancer despite using currently available strong opioid treatments and therefore have a very high clinical need. The data from this important trial further demonstrates the broad potential of Sativex, not only in its initial Multiple Sclerosis and neuropathic pain markets, but also in cancer and potentially other types of chronic pain. These positive results suggest that Sativex may represent a valuable new treatment option for this group of patients.

“We will now be actively reviewing the next steps, including a possible further Phase III confirmatory clinical trial, towards securing regulatory approvals for the use of Sativex in cancer pain.”

Sativex is currently the subject of regulatory applications in both the UK and Canada. A Qualifying Notice for approval in Canada was received in December 2004 for the use of Sativex in the treatment of neuropathic pain in Multiple Sclerosis. In both countries, upon approval, Sativex will be exclusively marketed by Bayer HealthCare.

Im glad to read yet another positive medicinal report for marijuana.
Its still sad that 40% of the cancer patients are still suffering more than they need to..........all the more reason to allow medicinal mj to go further in conventional medical treatments! Lets hope the laws everywhere can see it helping lives aswell as being a recreational drug for people with good taste.

[Harry Gypsna]

Its just a shame its something to do with this bloody company trying to santch our weed from underneath us to make a fortune of it, when they are part of the industry, which plays a major role in the conspiracy to keep the herb down. talk about fucking hypocrisy. they aiont interested in helping sick peole, they thinking, right, people are getting the idea that pot is helpful,, so they are trying to cash in, thats all it is.

[Noddy]

Hi all, I was thinking along similar lines to Harry. Whilst i'm very medi-weed, I had a feeling the day that they started talking about 'extracts' and 'tintures' that they were going to find a way to basically patent it. Watch out now for there COULD be a tiny backlash on the legalization movement. If they're making plenty of money out of sativex, they'll continue to do so without any side thought of legalization/allowing to grow etc. Still, it's certainly better news for those patients that need it, anyone suffering can have a slightly better chance of being able to relax now. Still don;t understand why only that one company is going to set to make some profit from it...
Noddy

[Nugs of Science]

I heard that the initial phase 3 results were encouraging. This statement is great and may help led to more cred for MMJ.
NoS

This is good news ..they got there spray from strains from horti farm from holland..they have breed plants with singular cannabinoids such as thc cbd cbn ex ...bad news is the sole controller of sativex is going to be bayer ..

take care all
greenfriend

"The other active arm of this study, GW’s THC extract did not show a significant effect in pain (p=0.24). This trial therefore suggests that Sativex is the more effective product for use in cancer pain."

What does this mean? What was the extract? How was it made? Did it contain CBD or pure THC? I would love to know.

[GMT]

I read this as showing that thc was not the pain killing agent but rather the CBD. Although I would have thought that this would show that rather than working with the sativa plants, they should be working with Indicas, which contain far more CBDs.

[sunnyside]

existing IC threads already discussing this topic:
https://www.icmag.com/ic/showthread.p...hlight=sativex
https://www.icmag.com/ic/showthread.p...hlight=sativex

[Paranoid-Watcha]

it's ok to use opiemes (some of the scariest drugs out thier, so scary i havn't even tryed them) as medicine.... but marijuana, no no thats way too dangerouse to use
fuckin DEA ....