Jump to content

Kevin Sabet Was Right?


slipstar059

Recommended Posts

Misleading US Advertisement

-GW

Response

19  May  2005

 

If you are in the United States and are accessing this web page in response to a US advertisement funded by Common Sense for Drug Policy, please note that this advertisement is not endorsed by GW Pharmaceuticals. Indeed, GW disputes and rejects the contents of the advertisement.

If you are in the United States and are accessing this web page in response to a US advertisement funded by Common Sense for Drug Policy, please note that this advertisement is not endorsed by GW Pharmaceuticals. Indeed, GW disputes and rejects the contents of the advertisement.

GW believes that this advertisement deliberately attempts to obscure the clear distinction between Sativex® and crude herbal cannabis / marijuana. The advertisement ignores the critical role of our unique formulations, their delivery system and the rigorous requirements of the scientific method. Such statements, in our opinion, deliberately seek to create confusion, among members of the public and the medical profession, concerning the nature of Sativex® and the goals of the company's program.

We are very disappointed that groups such as CSDP seek to exploit Sativex® for their own ends. GW is a pharmaceutical company focused solely on producing a medicine that can meet modern medical standards and serves the needs of patients. We are aggrieved that participants in the marijuana policy debate seek to use our information in an inappropriate and unsupportable manner.

Q: What is GW's position on crude herbal cannabis?

A: GW has never endorsed or supported the idea of distributing or legalizing crude herbal cannabis for medical use. In both our publications and presentations, we have consistently maintained that crude herbal cannabis can never meet the regulatory standards of the FDA and of other countries around the world. We have also repeatedly stressed that these regulatory processes provide important protections for patients, and we believe that any cannabis-derived medicinal product must be subjected to, and satisfy, such rigorous scrutiny.

Q: Why does GW believe that Sativex® is not just "liquid marijuana"?

A: Sativex® is not "liquid marijuana." Sativex® is a pharmaceutical product standardized in composition, formulation, and dose, administered by means of an appropriate alternative delivery system, which has been, and continues to be, tested in properly controlled preclinical and clinical studies. Crude herbal cannabis-often called "marijuana"-- in liquid or any other form, is none of those things.

Q: What impact should the approval of Sativex® in Canada have on the availability, for medical purposes, of crude herbal cannabis in the US and elsewhere?

A: The approval of Sativex® in Canada does not mean that any other product containing cannabis/marijuana should be made available as a prescription medicine in the US or elsewhere, unless and until it has gone through the same rigorous research, testing, and regulatory approval processes. Clearly, crude herbal cannabis or marijuana does not meet these criteria. We believe that other presentations of cannabis should not use Sativex® in an attempt to bypass standard processes for making legitimate medicines available.

Q: What type of cannabis-containing product should be made available to patients for medical use?

A: Only a scientifically-based cannabis-derived product, which meets the standards of modern pharmaceutical practice, and which has been approved by the appropriate regulatory agencies, would be suitable for distribution to patients as a prescription medicine.

Link to comment
Share on other sites

"Only a scientifically-based cannabis-derived product, which meets the standards of modern pharmaceutical practice, and which has been approved by the appropriate regulatory agencies, would be suitable for distribution to patients as a prescription medicine."

 

This may carry clout being stated by the only medical cannabis lab approved by the world?  

Now, still want to invest and financially support this company after reading their agendas above?  But wait, don't forget, they are doing research and helping many other people perhaps, just not in our own frikken country

Link to comment
Share on other sites

US Patent Granted for Sativex in Cancer Pain

 
US Patent Granted for Sativex in Cancer Pain
20  April  2011

Porton Down, UK; 20 April 2011: GW Pharmaceuticals plc (AIM: GWP) today announces that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent which protects the use of Sativex® as a treatment for cancer pain.

The patent, entitled “Pharmaceutical Compositions for the Treatment of Pain”, provides an exclusivity period until April 2025. The patent specifically covers a method of treating cancer related pain by administering a combination of the cannabinoids cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC), the two principal cannabinoids in Sativex®. In addition to this newly granted patent, Sativex®is protected by a number of other patents related to different aspects of the product.

Sativex®is currently in Phase III clinical development as a treatment for cancer pain. Cancer pain represents the lead indication for Sativex®in the United States, where the medicine is partnered with Otsuka Pharmaceutical Co. Ltd.

Dr Geoffrey Guy, GW’s Chairman, said, “The grant of this US patent covering Sativex®as a treatment for cancer pain is part of a broad platform of intellectual property rights which continue to be developed by GW. GW now has 35 patent families as well as other forms of protection such as plant variety rights and proprietary know-how. We believe that this matrix of intellectual property provides GW with a unique position to benefit from the rich promise within the field of cannabinoid therapeutics.”

Sativex®is approved in the UK, Spain, Czech Republic, Canada and New Zealand as a treatment of Multiple Sclerosis spasticity.

Link to comment
Share on other sites

GW Pharmaceuticals Announces US Patent Allowance for SATIVEX® Formulation Spray Device

22  April  2013

Follows Recent Notice of Allowance for Sublingual Delivery of Sativex Formulation Patent-

Porton Down, UK; 22 April 2013: GW Pharmaceuticals plc (AIM: GWP), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/606,742, a patent application directed to the spray device of its Sativex® product formulation. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application.

 

The patent claims a metered valve pump spray device consisting of a liquid cannabis extract, in propylene glycol and ethanol, which is adapted to spray a dose towards a patient’s sublingual mucosa. The issued patent from this application is expected to expire in March 2021.

 

“This Notice of Allowance directed to the Sativex delivery device comes soon after the 13/607,897 Notice of Allowance directed to a method of sublingual delivery of the Sativex pharmaceutical formulation.  Not only does GW have claims directed to the method of sublingual delivery of the Sativex formulation, but it also has claims directed to the device within which it is contained,” stated Justin Gover, GW’s Chief Executive Officer. “In total, we now have seven different patent families containing one or more pending or issued patents relating to Sativex.”

 

GW’s intellectual property portfolio includes multiple patent families with issued or pending claims directed to plants, plant extracts, extraction technology, pharmaceutical formulations, drug delivery and the therapeutic uses of cannabinoids, as well as plant variety rights, know-how and trade secrets.  

 

GW’s granted patents and pending applications (if they were to issue) in the US relating to Sativex would expire on various dates between 2021 and 2026, excluding possible patent term extensions.

 

In the US, Sativex is currently in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and elsewhere.

 

Link to comment
Share on other sites

The formulations can be proprietary, but you can't overdose on cannabis, so if you have an over-abundance of THC CBD, you'll still receive the same treatment, as their formulations.  It might not be cost-effective for a company to give you an over-abundance of anything, but if your doing everything yourself, and it's giving you your quality of life back, the cost can be justified.

Link to comment
Share on other sites

New patent allowance:

GW Pharmaceuticals plc Announces US Patent Allowance for Use of Cannabidivarin (CBDV) in Treating Epilepsy
GW Pharmaceuticals plc 4 hours ago 
 

LONDON, April 27, 2015 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWP.L) (GWPH) ("GW") announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/075,873, a patent application which covers the use of cannabidivarin (CBDV) for treating epilepsy.

 

The subject patent claims cover CBDV, a non-psychoactive cannabinoid extracted from the cannabis plant, for use in the treatment of patients with epilepsy and specifically for the control of generalised or temporal lobe seizures. This patent covers CBDV alone or in combination with standard anti-epileptic drugs. The issued patent from this application will provide an exclusivity period until 30 March 2031.

"This patent is important as we believe that CBDV has the potential to become an important new treatment option in the field of epilepsy," stated Justin Gover, GW's Chief Executive Officer. "Whilst the primary focus of GW's epilepsy research program remains on Epidiolex in pediatric epilepsy, we believe that CBDV may offer an additional treatment advance in this therapeutic area in the medium and longer term."

In 2014, GW completed a Phase 1 clinical trial of its CBDV product candidate, known as GWP42006, and expects to commence a Phase 2 study in adult patients with epilepsy in the second quarter of 2015.

In addition to CBDV, GW continues to advance its product candidate Epidiolex®, a liquid formulation of pure cannabidiol (CBD). GW recently commenced two Phase 3 clinical trials of Epidiolex in Dravet syndrome and expects to commence two Phase 3 clinical trials in Lennox-Gastaut syndrome in the second quarter of 2015. GW also recently announced its intent to commence clinical development of Epidiolex in an additional pediatric epilepsy indication, Tuberous Sclerosis Complex (TSC), and expects to commence Phase 3 clinical development in TSC later this year.

1: Hill et al, British Journal of Pharmacology, September 2012

About Epilepsy

Epilepsy is a complex neurological disorder characterized by spontaneous recurrence surges of electrical activity in the brain resulting in unprovoked seizures. Epilepsy is estimated to affect 50 million people worldwide including, according to the Centers for Disease Control and Prevention, 2.2 million people in the United States. Drug therapy remains ineffective for seizure control in approximately 30% of patients with epilepsy because either the drugs do not control the seizures or the patients cannot tolerate the side effects. Currently available drugs can cause significant side effects particularly affecting movement and cognition that can adversely affect the quality of life for epileptic patients.

Link to comment
Share on other sites

GW Pharmaceuticals Receives Orphan Drug Designation From FDA for Cannabidiol for the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy

GW Pharmaceuticals plc April 24, 2015 7:00 AM GlobeNewswire
 

LONDON, April 24, 2015 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWP.L) (GWPH) ("GW") announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Cannabidiol (CBD) for use in treating newborn children with neonatal hypoxic-ischemic encephalopathy (NHIE). NHIE is acute or sub-acute brain injury due to asphyxia caused during the birth process and resulting from deprivation of oxygen during birth (hypoxia).

 

The incidence of NHIE is 1.5 to 2.8 per 1,000 births in the United States, or, 6,500 to 12,000 cases per year. Of these, 35% are expected to die in early life and 30% may suffer from permanent disability. There are currently no FDA-approved medicines specifically indicated for NHIE.

GW has developed an intravenous CBD formulation for use in this patient population. GW held a pre-IND meeting with the FDA and expects to submit an Investigational New Drug Application (IND) in mid-2015 and to commence a Phase 1 trial in the second half of 2015.

GW has been conducting pre-clinical research into the neuroprotective effects of CBD in animal models of NHIE since 2008. Publications from this research have shown that CBD reduces neurologic disability across a range of newborn animal models of brain hypoxia.

"GW continues to explore the opportunity for the development of cannabinoids in rare pediatric conditions characterized by significant unmet need," stated Justin Gover, GW's Chief Executive Officer. "This orphan drug designation for cannabidiol for the treatment of newborn children with neonatal hypoxic-ischemic encephalopathy follows several years of pre-clinical evaluation and we look forward to advancing a clinical development program in this important medical condition later this year."

About Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition -- generally a disease or condition that affects fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active moiety to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period for that drug and use, unless the applicant is unable to assure sufficient quantities of the drug or another applicant is able to demonstrate that its version of the drug is clinically superior

Link to comment
Share on other sites

GW Pharmaceuticals Receives Orphan Drug Designation From FDA for Cannabidiol for the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy

GW Pharmaceuticals plc April 24, 2015 7:00 AM GlobeNewswire
 

LONDON, April 24, 2015 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWP.L) (GWPH) ("GW") announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Cannabidiol (CBD) for use in treating newborn children with neonatal hypoxic-ischemic encephalopathy (NHIE). NHIE is acute or sub-acute brain injury due to asphyxia caused during the birth process and resulting from deprivation of oxygen during birth (hypoxia).

 

The incidence of NHIE is 1.5 to 2.8 per 1,000 births in the United States, or, 6,500 to 12,000 cases per year. Of these, 35% are expected to die in early life and 30% may suffer from permanent disability. There are currently no FDA-approved medicines specifically indicated for NHIE.

GW has developed an intravenous CBD formulation for use in this patient population. GW held a pre-IND meeting with the FDA and expects to submit an Investigational New Drug Application (IND) in mid-2015 and to commence a Phase 1 trial in the second half of 2015.

GW has been conducting pre-clinical research into the neuroprotective effects of CBD in animal models of NHIE since 2008. Publications from this research have shown that CBD reduces neurologic disability across a range of newborn animal models of brain hypoxia.

"GW continues to explore the opportunity for the development of cannabinoids in rare pediatric conditions characterized by significant unmet need," stated Justin Gover, GW's Chief Executive Officer. "This orphan drug designation for cannabidiol for the treatment of newborn children with neonatal hypoxic-ischemic encephalopathy follows several years of pre-clinical evaluation and we look forward to advancing a clinical development program in this important medical condition later this year."

About Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition -- generally a disease or condition that affects fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active moiety to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period for that drug and use, unless the applicant is unable to assure sufficient quantities of the drug or another applicant is able to demonstrate that its version of the drug is clinically superior

 

Don't forget, there's no medical use for Cannabis.  Right?  What does GW know?

Link to comment
Share on other sites

  • 3 weeks later...

I'm pretty sure it's alcohol based, but they use butane as a propellent.

sativex has no propellent. its a pump sprayer

 

http://www.medicines.org.uk/emc/PIL.23228.latest.pdf

6. Content of the pack and other information

What Sativex contains

• The active substances are cannabis extracts. Each millilitre (ml) contains 38-44 mg and 35-42 mg of two extracts (as soft extracts) from Cannabis sativa

L., leaf and flower, corresponding to 27 mg/ml delta-9-tetrahydrocannabinol

(THC) and 25 mg/ml cannabidiol (CBD). Each 100 microlitre spray contains

2.7 mg THC and 2.5 mg CBD.

• The other ingredients (excipients) are ethanol, propylene glycol and

peppermint oil.

Link to comment
Share on other sites

also whatever solvent is being used- the essential oil of cannabis is not in solution. My oil does not separate when infused with correct solvents. How in the world can this be a controlled dosage if not completely in solution? one pump could be some slop with a dot of oil, and the other could clog the nozzle with a oyster chunk of resin.

Link to comment
Share on other sites

where do you see it seperating?

 

that video the guy has the bowl of sativex on a heat radiator to dry out. i thought the same thing but it looks fairly stable until he applies the heat.

 

of course it does say shake a few times in the instructions.

Edited by t-pain
Link to comment
Share on other sites

My oil does not separate when infused with correct solvents. How in the world can this be a controlled dosage if not completely in solution?

 

It doesn't contain a complete extract, only two components. It could be micellized into extremely small drops so while technically separate they are so small it doesn't matter.

Link to comment
Share on other sites

Join the conversation

You can post now and register later. If you have an account, sign in now to post with your account.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
×
×
  • Create New...