Cannabis-Based Medicines

[Wise Young]

• (2003). Cannabis-Based Medicines - GW Pharmaceuticals: High CBD, High THC, Medicinal Cannabis - GW Pharmaceuticals, THC:CBD. Drugs R D 4:306-309. Summary: GW Pharmaceuticals is undertaking a major research programme in the UK to develop and market distinct cannabis-based prescription medicines [THC:CBD, High THC, High CBD] in a range of medical conditions. The cannabis for this programme is grown in a secret location in the UK.It is expected that the product will be marketed in the US in late 2003. GW's cannabis-based products include selected phytocannabinoids from cannabis plants, including D9 tetrahydrocannabinol (THC) and cannabidiol (CBD). The company is investigating their use in three delivery systems, including sublingual spray, sublingual tablet and inhaled (but not smoked) dosage forms. The technology is protected by patent applications. Four different formulations are currently being investigated, including High THC, THC:CBD (narrow ratio), THC:CBD (broad ratio) and High CBD. GW is also developing a specialist security technology that will be incorporated in all its drug delivery systems. This technology allows for the recording and remote monitoring of patient usage to prevent any potential abuse of its cannabis-based medicines.GW plans to enter into agreements with other companies following phase III development, to secure the best commercialisation terms for its cannabis-based medicines. In June 2003, GW announced that exclusive commercialisation rights for the drug in the UK had been licensed to Bayer AG. The drug will be marketed under the Sativex((R)) brand name. This agreement also provides Bayer with an option to expand their license to include the European Union and certain world markets.GW was granted a clinical trial exemption certificate by the Medicines Control Agency to conduct clinical studies with cannabis-based medicines in the UK. The exemption includes investigations in the relief of pain of neurological origin and defects of neurological function in the following indications: multiple sclerosis (MS), spinal cord injury, peripheral nerve injury, central nervous system damage, neuroinvasive cancer, dystonias, cerebral vascular accident and spina bifida, as well as for the relief of pain and inflammation in rheumatoid arthritis and also pain relief in brachial plexus injury. The UK Government stated that it would be willing to amend the Misuse of Drugs Act 1971 to permit the introduction of a cannabis-based medicine.GW stated in its 2002 Annual Report that it was currently conducting five phase III trials of its cannabis derivatives, including a double-blind, placebo-controlled trial with a sublingual spray containing High THC in more than 100 patients with cancer pain in the UK. Also included is a phase III trial of THC:CBD (narrow ratio) being conducted in patients with severe pain due to brachial plexus injury, as are two more phase III trials of THC:CBD (narrow ratio) targeting spasticity and bladder dysfunction in multiple sclerosis patients. Another phase III trial of THC:CBD (narrow ratio) in patients with spinal cord injury is also being conducted. Results from the trials are expected during 2003.Three additional trials are also in the early stages of planning. These trials include a phase I trial of THC:CBD (broad ratio) in patients with inflammatory bowel disease, a phase I trial of High CBD in patients with psychotic disorders such as schizophrenia, and a preclinical trial of High CBD in various CNS disorders (including epilepsy, stroke and head injury).GW Pharmaceuticals submitted an application for approval of cannabis-based medicines to UK regulatory authorities in March 2003. Originally GW hoped to market cannabis-based prescription medicines by 2004, but is now planning for a launch in the UK towards the end of 2003.Several trials for GW's cannabis derivatives have also been completed, including four randomised, double-blind, placebo-controlled phase III clinical trials conducted in the UK. The trials were initiated by GW in April 2002, to investigate the use of a sublingual spray containing THC:CBD (narrow ratio) in the following medical conditions: pain in spinal cord injury, pain and sleep in MS and spinal cord injury, neurop spinal cord injury, neuropathic pain in MS and general neuropathic pain (presented as allodynia). Results from these trials show that THC:CBD (narrow ratio) caused statistically significant reductions in neuropathic pain in patients with MS and other conditions. In addition, improvements in other MS symptoms were observed as well.PhaseII studies of THC:CBD (narrow ratio) have also been completed in patients with MS, spinal cord injury, neuropathic pain and a small number of patients with peripheral neuropathy secondary to diabetes mellitus or AIDS. A phase II trial of THC:CBD (broad ratio) has also been completed in a small number of patients with rheumatoid arthritis, as has a trial of High CBD in patients with neurogenic symptoms. A phase II trial has also been evaluated with High THC in small numbers of patients for the treatment of perioperative pain. The phase II trials provided positive results and confirmed an excellent safety profile for cannabis-based medicines.GW Pharmaceuticals received an IND approval to commence phase II clinical trials in Canada in patients with chronic pain, multiple sclerosis and spinal cord injury in 2002.Following meetings with the US FDA, Drug Enforcement Agency (DEA), the Office for National Drug Control Policy, and National Institute for Drug Abuse, GW was granted an import license from the DEA and has imported its first cannabis extracts into the US. Preclinical research with these extracts in the US is ongoing.

[calico]

This looks like it might be right up our alley. Any ideas where the trials are going on in the US?

Dr. Wise, what do think of this?

Calico

[Wise Young]

I hope that the trials will begin soon. Wise.

[mike]

Do we have any idea at this point which hospitals in the U.S. will be taking part in trials?

mike

[Wise Young]

mike,

Here are some links to more information:

http://www.gwpharm.com/ web site for GW Pharmaceuticals with a news story indicating their successful raising of £20 million for their research in June 2003. So, this is not a fly-by-night company.

According to this profile of Business profile for GW Pharmaceuticals, they have already reported positive results from four phase 3 clinical trials in patients with MS and neuropathic pain. http://atlas.pharmalicensing.com/company/dc/2785#profile

According to a news report in November 2002, the company was "confident" that the first drugs will be available by prescription in 2004 http://www.ananova.com/business/story/sm_702713.html?menu=

The company, however, is continuing to lose money http://www.ananova.com/business/story/sm_496827.html?menu=
at the rate of £7.2 million last year.

Their share prices more than doubled in the past six months and continues to be very high http://www.thisismoney.com/detail.asp?epic=GWP

Their first product is Sativex, an under the tongue spray for multiple sclerosis that "could be on prescription in the UK" by December. Bayer signed up in May asa marketing partner in a deal that includes milestone payments of £25 million and a cut of product revenues. http://www.thisismoney.com/20030821/nm66823.html

The company has been collaborating with Dutch plant-breeding company Hortapharm to grow some 200000 plants since 1998, harvested in 1999, and started in clinical trial. http://www.ukcia.org/medical/gwpharmaceuticals.html

The company has started clinical trials in Canada http://production.investis.com/gwpharmaceuticals/releases/2001-8-14/?version=1 and given the recent easing of cannibis laws in Canada, I suspect that it may be approved in Canada.

They have a sub-lingual spray, a sublingual tablet, and an inhaler. The question is whether these will be approved in the United States. I suspect that there will be a political battle over this.

[steve farris]

I'm in the UK and have been on blind trial and am now taking the thc:cbd spray at the moment. It's not bad but not as effective as I had hoped. Great for sleep though!Originally posted by mike:

Do we have any idea at this point which hospitals in the U.S. will be taking part in trials?

mike

Does it make you feel "high"? Do you feel functional when you use it, or in an altered state at all? Thanks! Carol http://sci.rutgers.edu/forum/images/smilies/smile.gif

Piglet sidled up to Pooh from behind. "Pooh!", he whispered. "Yes, Piglet?" "Nothing", said Piglet, taking Pooh's paw. "I just wanted to be sure of you."

[steve farris]

To get it to work you need to take just enough to start making you high. Overdose and you just can't function. You can't take it less than 4 hrs. before driving and if it's mixed with alcohol it blows your mind.I've found it takes the 'spikes' off the pain and tends to sort of blur the edges of it. The pain is still there but the spray makes it easier to handle. Biggest drawback is the taste which is really bad. Originally posted by Piglet:

Does it make you feel "high"? Do you feel functional when you use it, or in an altered state at all? Thanks! Carol http://sci.rutgers.edu/forum/images/smilies/smile.gif

Piglet sidled up to Pooh from behind. "Pooh!", he whispered. "Yes, Piglet?" "Nothing", said Piglet, taking Pooh's paw. "I just wanted to be sure of you."

Thank you for the info Benson. http://sci.rutgers.edu/forum/images/smilies/smile.gif I am interested on my husband's behalf. He is in a lot of pain most of the time and nothing seems to help it much...if used like you say, this spray seems like it would would make him feel "less himself" no more than the hydrocodone he takes now, which makes him very tired, OR hypes him up, depending on how much he takes. Almost high, does not sound bad...still functional, but taking the edge off. I appreciate your reply! Carol http://sci.rutgers.edu/forum/images/smilies/smile.gif

Piglet sidled up to Pooh from behind. "Pooh!", he whispered. "Yes, Piglet?" "Nothing", said Piglet, taking Pooh's paw. "I just wanted to be sure of you."

[diaspora]

Since this thread is back
I'd like to know what dr wise thinks about cannabis and neuropathic pain in today's world and if things have changed since 2003.

I have tried sativex and find it to be a joke substitute for cannabis.

[zagam]

GW won't make money unless trials are successful and they end up with a monopoly. They may own their plants, but not other plants which could do similar. It is an ancient orphan drug. Governments that fund health care systems, not companies are the only ones that could gain by not excluding plant based drugs.

Most "research" is _not_ in Google scholar. <http://scholar.google.com/scholar?q=paracetamol%20canabinoid> Some pot heads use paracetamol to potentiate cannabis. <http://onlinelibrary.wiley.com/doi/10.1016/S1754-3207(11)70722-2/abstract> Many have their own "research" that they share informally while passing it around.

Some weed is more mellow. This is better for pain and the inevitable anxiety of pain. However, black market has increased THC, the one that warps the mind.

[garyv]

I have been doing a lot of research on the use of cannabis , just checking out a lot of documentarys and have used it a few times in the past . I dont dare smoke it now because I get my meds now from controllled pain clinics and there I have to give random urine samples so I cant chancce that . Also Florida it is still illegal for medicinal use.
There are actually a few good documentaries about the use of it for pain all the way to cancer when made into a paste or liquid it helps healing .
But Florida is getting in line for medicinal use laws to be passed a soon as next year and I will be first in line to try it . There are different strains that help different problems from nueropathic nearve pain to arthritus pain.
So if interested check out either of the movie channels like netfilx or hulu plus and do a medical marijuana search and watch a few .
And also for getting "stoned" when using you dont need that much just a few hits and try that first . With the different strains they act in different ways .
It is still like starting a new pain medication you find out how much you need and thats where you stop .
There is definatly a stigma about marijuana that some people still have that it is just for getting high and not able to be used as medicine.
One of the main reasons it is not used medicinally is the pharmicutical companies can patent a plant , and yes the do have marinol and sativex and probably a few others so that tells me that if they have done that much research and money into the pill that means something in it works.
A few years ago when I broke my femur I was in the emergency room at 4 in the morning and was talking to a Dr on the the late shift and he even suggested that I try smoking a little marijuanna for my shoulder pain and he also stated that he thought the benifits of marijuanna where great with a lot of differnt pains and that Florida should be legal for medicinal use.