Setback in Medical Marijuana Study

Setback in Medical Marijuana Study

Efforts to get a medical marijuana spray approved as a drug in the U.S. suffered a setback when GW Pharmaceuticals (NASDAQ: GWPH) reported the results of a clinical trial showing that Sativex worked no better than a placebo in relieving cancer pain.

Sativex is composed primarily of two cannabinoids: CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol), which are administered in an oral spray. Sativex is already being sold in Europe, Canada and Mexico to treat muscle spasticity caused by multiple sclerosis. Canada also allows Sativex to be used for relief of neuropathic pain and advanced cancer pain.

Image courtesy of GW Pharmaceuticals

Image courtesy of GW Pharmaceuticals

The spray is not currently approved for use in the U.S. for any condition, but is getting a “fast track” review from the FDA as a treatment for cancer pain. It is estimated that 420,000 cancer patients in the U.S. suffer from pain that is not well controlled by opioid pain medications.

“Unfortunately in this initial Phase 3 trial, Sativex did not meet the primary end point of demonstrating a statistically significant difference from placebo, as assessed on the patient assessment of pain using a 0 to 10 numeric rating scale,” said Justin Gover, GW’s CEO in a conference call with analysts.

The randomized double-blind placebo-controlled study recruited 399 cancer patients on opioid pain medication in the U.S., Mexico and Europe. They were given Sativex or a placebo at a dose range of 3-to-10 sprays per day over a 5-week treatment period. Patients remained on opioid therapy during the study. Sativex was well tolerated, with the only side effects in some patients being dizziness and somnolence.

This was the first of three Phase 3 trials of Sativex carried out by GW in collaboration with Otsuka Pharmaceutical. The companies are still hopeful that positive results from the other two trials will enable them to submit a new drug application (NDA) to the FDA.

“Although today’s data is clearly a setback, we believe that if these two additional Phase 3 trials are positive, the data set would allow us to submit an NDA with the FDA and as such we look forward to the data from these studies later in the year,” said Gover.

Results from a second pivotal trial are expected in the second quarter of 2015. GW and Otsuka are in the process of conducting a third Phase 3 trial, which is expected to enroll approximately 540 patients and is designed to provide additional information on the effects of Sativex in treating opioid-resistant cancer pain.

“We believe that cannabinoid therapy offers a potentially novel approach as a co-analgesic to provide pain relief beyond opioid therapy.  Too many patients with advanced cancer do not attain adequate pain relief from an opioid regimen, or experience unacceptable opioid side effects,” said Dr. Marie Fallon, a professor of Palliative Care at University of Edinburgh and the principal investigator.

“Whilst I am naturally disappointed that this first trial did not achieve its primary endpoint, I remain optimistic about the potential of Sativex and look forward to the upcoming data from the remaining Sativex Phase 3 trials later this year.”

Authored by: Pat Anson, Editor

There are 4 comments for this article
  1. Ron at 6:45 am

    I’m on COT for 15 years now. High doses of OxyContin and many rescue drugs with very little relief. High tolerance. I have no quality of life at all. Just sitting here waiting to die. I tried cannabis and loved it. Never felt better. As luck and law have it, I was random drug tested right after my first try and am now denied any treatment? Now I have to consider moving from my home of 25 years just to get medical treatment?! Insanity. I agree there is a pill epidemic along with many other epidemics. All I wanted was to find something to help with my pain and because it’s illegal, I failed my first drug test in years, I had to switch doctors and now being “random” drug tested EVERY MONTH! Bullsh$t. The stuff works wonders and the I know the history of why it is illegal. IMO alcohol and cigs are so much worse. Neither of which I do. This naturally occurring plant needs to be legalized. It’s a win/win situation for all.

  2. Kurt W.G. Matthies at 2:21 pm

    Speaking of facts, of what “damage the opiates do to the rest of the systems in their bodies” do you speak?

    Incidentally, people using COT (chronic opioid therapy) are opioid tolerant and rarely die of opioid poisoning or what you call “overdose.” Still opioids do suppress respiration and smooth muscle contraction.

    With all treatment options there are risks and benefits. One must evaluate both and act in accordance to one’s therapeutic priorities. The same decision process is required whether one is considering COT or therapies associated with MMJ.

  3. Scientist at 9:07 pm

    The problem with the GW phase 3 trial is that it was based on a fixed dosage, which doesn’t fit with the way Medical Marijuana works.
    Marijuana has an incredibly wide therapeutic index. Its impossible to overdose on. Talk with actual Cancer patients. When they use Medical Marijuana, the titrate the dosage until they get the desired effect. Marijuana is the only pain killer its impossible to overdose on. When people use opiates, for either managing pain or other purposes, they develop a tolerance to the opiate’s pain killing effect, but not to its effects in suppressing CNS (Central Nervous System) effects or to the damage the opiates do to the rest of the systems in their bodies, and they OVERDOSE ON OPIATES AND DIE.

    Marijuana is unique in the fact that its impossible to overdose on.

    Everyone is entitled to their own opinions but not their own facts.

  4. Jennifer at 5:51 am

    The problem is, removing only certain components from plants is RARELY as effective as using the whole plant – there are hundreds of compounds in the whole plant that work synergistically with the CBD and THC to create better pain relief. By creating a pharmaceutical with only a few components, you miss out on this positive effect. For God’s sake, just legalize marijuana itself!