Marijuana Spray Gets ‘Fast Track’ Review from FDA

Marijuana Spray Gets ‘Fast Track’ Review from FDA

The U.S. Food and Drug Administration has given “Fast Track” designation to Sativex – a medical marijuana spray – for the treatment of pain in patients with advanced cancer. The move will expedite an FDA review of Sativex, which is currently in a Phase III clinical study for cancer pain.

“The award of Fast Track designation for Sativex represents important recognition by the FDA of the potential of this medicine to address significant unmet needs in the treatment of cancer pain,” said Justin Gover, CEO of British-based GW Pharmaceuticals (NASDAQ: GWPH), which is developing Sativex in the U.S. in collaboration with Otsuka Pharmaceutical Co. Ltd.

Image courtesy of GW Pharmaceuticals

Image courtesy of GW Pharmaceuticals

“Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications. We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn.”

Sativex is composed primarily of two cannabinoids: CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol), which are administered in an oromucosal spray called nabixmols.

Sativex is already being sold in Europe, Canada and Mexico to treat muscle spasticity caused by multiple sclerosis (MS). Canada also allows Sativex to be used for relief of neuropathic pain and advanced cancer pain. The spray is not currently approved for use in the U.S. for any condition.

The FDA’s decision to speed up the review process for Sativex is the latest indication that medical marijuana is gaining broader acceptance among patients, healthcare providers and the medical establishment.

Last month the American Academy of Neurology became one of the first medical organizations in the U.S. to endorse the use of medical marijuana. The Academy, which represents over 27,000 neurologists, issued new guidelines saying that oral cannabis, medical marijuana pills and medical marijuana spray may help ease pain and other symptoms caused by MS.

Initial data from the Phase III study on cancer patients is expected around the end of 2014. It is estimated that 420,000 cancer patients in the U.S. suffer from pain that is not well controlled by opioid pain medications.

A 2012 study of Sativex found a 26% improvement in pain among cancer patients who received a low dosage of nabixmols. Patients receiving low and medium doses of nabiximols also said they slept better. No significant improvement in pain was seen in patients in a high dosage group, who also didn’t tolerate the high dose well. Side effects included nausea and loss of cognitive function.

Opioid therapy is the standard treatment for cancer patients in pain. However, a significant number of patients continue to experience pain that isn’t controlled effectively at safe and tolerable opioid doses.

A recent online survey of over 1,300 fibromyalgia patients conducted by the National Pain Foundation found that medical marijuana is far more effective than any of the three prescription drugs approved by the FDA to treat fibromyalgia.

A spokesman for GW Pharmaceuticals told National Pain Report the company is not currently seeking FDA approval of Sativex as a treatment for fibromyalgia.

GW is developing other cannabinoid medicines to treat epilepsy, glioma, ulcerative colitis, type-2 diabetes, and schizophrenia.

Authored by: Pat Anson, Editor

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I have read the above comments and would like to recommend that you both read a book entitled My Medicine by Irvin Rosenfeld. Irvin has a condition called Multiple Congenital Cartilaginous Exostosis and Pseudopseudohypoparathyroidism he was ‘prescribed’ medical marijuana by the Federal Government of USA in November 1982. He is 1 of only 4 patients in the USA today who have medical marijuana sent to them (in cigarette form) by the Federal Government since taking it Irvin has been able to stop completely ALL his man-made manufactured medicines (and all their side effects). If the government really wanted to show results why has he and the others on this program never been monitored for progress……because the Government cannot admit it was wrong in 1937 and its wrong today!

When will all chronic pain be treated like cancer pain? Is 1 – 10 different on the cancer scale? I wouldn’t wish cancer on anyone (except me) and I don’t mean to understate its seriousness but, having been both a cancer patient and a chronic pain patient I can tell you, it is the truth.

Cancer is immediate validation, immediate sympathy and empathy. It is 4 doctors rushing to your side to give you the best and the strongest drugs. I was the only one unhappy when my cancer went into remission. I still miss the attention and proper pain meds.

Doctors, family, friends, co-workers, employers, everyone, treats cancer different. No one questions any type of cancer but every type of pain disease puts you under scrutiny with your closest inner circle of people you trust to support you in a time of need like getting a chronic pain diagnosis. Now, imagine the response from the same people if you got a cancer diagnosis.
We need better advertising!

John Quintner, Physician in Pain Medicine

@ David. Let us all be clear as to what we are discussing. According to the US National Institute on Drug Abuse:

The term “medical marihuana” is generally used to refer to the whole unprocessed marihauna plant or its crude extracts, which are not recognised or approved as medicine by the US Food and Drug Administration (FDA). But scientific study of the active chemicals in marihuana, called cannabinoids, has led to the development of two FDA-approved medications already, and is leading to the development of new pharmaceutical that harness the therapeutic benefits of cannabinoids while minimizing the harmful side effects (including the “high”) produced by eating or smoking marihuana leaves.

@ Dave. In my opinion, scientific research in this context should be primarily focused upon solving practical problems. Setting the agenda is the responsibility of the society in which the problems have been identified. This is called “applied science”.

Yes, we do live in an uncertain world and no amount of endeavour, scientific or otherwise, can alter this sobering fact.

Yes, there are many scientific studies that in retrospect can be seen as having been “poor and unnecessary”. Other studies have lead to the drawing of premature conclusions, sometimes with harmful consequences, as you have rightly observed.

I will share with you the observation of Dr Homer William Smith [1895-1962], an American physiologist and advocate for science:

A scientist is one who, when he does not know the answer, is rigorously disciplined to speak up and say so unashamedly; which is the essential feature by which modern science is distinguished from primitive superstition, which knew all the answers except how to say, “I do not know.”

Finally, as Sir Winston Churchill [1874-1965] once remarked: Scientists should be on tap, but not on top.


John- I am all in favor of more research on marihuana, if the public and not pharmaceutical companies or biased researchers decide what research is to be done. In addition, research, in my opinion, should be results oriented.
Official recommendations- as you know can be riddled with bias and controversy- Zohydro, Vioxx, Avandia, the 500 guidelines for hypertension- to name very few- were, arguably flawed.
I dont think science in the short run,is necessarily focused on answering questions. There are in the words of one author on clinical trials, many “poor and unneccessary studies”.
Terror management theory suggests we seek something to ally our anxieties, discomfort, mortal fears. For some science is the answer to our mortal fears and we are blinded by our need to believe science will “save us”. For some it is the doctor who will save us, for others money, religion, etc.
I am not against science- i read research almost every day. But, I believe in Franklins Law- the only certainty is death- Just as Seneca indicated- the greatest certainty once anything is alive is death. Filling our head full of false imaginings or the omnipotence of thought- is very human, but while comforting psychologically, often leads to mistakes.

Opinions are that and only that regardless if you are a Doctor or a patient. The Facts are that the U.S. Government holds a patent from Oct.7,2003 that says that Marijuana has medical properties. Also the Government takes the stand that Marijuana is a schedule 1 drug with no medical value. A continued example of the hype and misinformation our Government is famous for. I have to wonder who runs this country. The Government? The Pharmaceutical Companies and Big Business? Certainly not the people who are in the majority in favor of medical Marijuana.

I can’t wait for this ago that I can switch from Marinol/dronabinol (THC only) to this, which includes ALL cannabinoids!

John Quintner, Physician in Pain Medicine

In my opinion, despite the vox populi, more evidence is needed before “medical marihuana” can be officially recommended as a safe and sure treatment for the many sufferers of chronic widespread pain (aka Fibromyalgia Syndrome).

A recent comprehensive review of the randomized clinical trials in which cannabinoids have been used in the treatment of chronic non-cancer pain concluded that the efficacy of these substances is at best modest, and that concerns over its safety and abuse potential have not been allayed.

The authors conclude that more clinical trials utilizing larger numbers of participants and of longer duration will be necessary to fully answer these questions.

Reference: Lynch ME, Campbell F. Cannabinoids for the treatment of chronic non-cancer pain: a systematic review of randomized clinical trials. British Journal of Clinical Pharmacology. 2011; 72: 735-744. [a freely downloadable paper]