High Hopes Ride on Cannabis Painkillers Amid Opioid Crisis 

A handful of drugmakers are taking their first steps toward developing marijuana-based painkillers, alternatives to opioids that have led to widespread abuse and caused the U.S. health regulator to ask for a withdrawal of a popular drug this month.

The cannabis plant has been used for decades to manage pain and there are increasingly sophisticated marijuana products available across 29 U.S. states, as well as in the District of Columbia, where medical marijuana is legal.

There are no U.S. Food and Drug Administration (FDA)-approved painkillers derived from marijuana, but companies such as Axim Biotechnologies Inc, Nemus Bioscience Inc and Intec Pharma Ltd have drugs in various stages of development.

The companies are targeting the more than 100 million Americans who suffer from chronic pain, and are dependent on opioid painkillers such as Vicodin, or addicted to street opiates including heroin.

Opioid overdose, which claimed celebrities including Prince and Heath Ledger as victims, contributed to more than 33,000 deaths in 2015, according to the Centers for Disease Control and Prevention.

Earlier this month, the FDA asked Endo International Plc to withdraw its Opana ER painkiller from the market, the first time the agency has called for the removal of an opioid painkiller for public health reasons. The FDA concluded that the drug’s benefits no longer outweighed its risks.

Multiple studies have shown that pro-medical marijuana states have reported fewer opiate deaths and there are no deaths related to marijuana overdose on record.(reut.rs/2r74Sbe)

But marijuana-derived drugs could take longer than usual to hit the market as the federal government considers marijuana a “schedule 1” substance – a dangerous drug with no medicinal value – making added approvals necessary. Any drug typically takes at least a decade from discovery to approval.

It could be worth the wait.

An FDA-approved marijuana-based painkiller would ensure consistent dosing and potency, and availability across the country, analysts and experts said.

“Doctors like to be able to write a prescription and know that whatever they wrote is pure and from a blinded, placebo-controlled trial,” California-based Nemus’s CEO Brian Murphy told Reuters.

Nemus is testing its product – a synthetic version of the non-psychoactive CBD compound found in cannabis – on rats with chronic pain and expects to report data later this year.

Rival Axim, whose North American headquarters is in New York, is conducting preclinical studies on a chewing gum containing synthetic CBD and THC, a psychoactive compound found in marijuana. The company expects to submit an FDA application to start a trial on opioid-dependent patients this year.

Leading the pack is Israel-based Intec, which recently announced the start of an early-stage study testing its painkiller made of natural CBD and THC extracts.

Independent scientists are also looking to find natural, non-pharmaceutical alternatives to opioids, but many have said it is difficult to access government-approved marijuana to conduct research due to supply restrictions.

“It’s taken me seven years to get the DEA license,” said Dr Sue Sisley, who is planning to conduct an FDA-regulated study evaluating whether marijuana can help opioid-dependent patients.

There could soon be other alternatives as well. Pfizer Inc and Biogen Inc are among a clutch of drugmakers developing non-opioid painkillers that are in advanced clinical studies.

Still, opioid painkillers are here to stay and will continue to be widely prescribed, especially for patients with acute and post-surgical pain.

The Republican healthcare bill unveiled on Thursday has proposed a drastic cut to the Medicaid budget and could gut, what advocates say, is essential coverage for drug addiction treatment, potentially hampering the fight against opioid abuse.

Original Reuters article here.

2 Responses to High Hopes Ride on Cannabis Painkillers Amid Opioid Crisis 

  • How absolutely incredible, actually insulting, to read these accounts of the US Government stumbling along, desperately trying to keep the dreaded cannabis from its citizens…… to keep it as a Schedule 1 forbidden drug, telling US citizens it has NO MEDICAL VALUE OR USE. No matter then, that in fact it’s been used as medicine for thousands of years by people across the globe, and we hear of no problems…. no matter that it’s been studied by the Indian government and the British government and most recently by various US government organizations such as that commissioned around 1930 by Mayor La Guardia of New York City, and no problems were found. Richard Nixon even rejected a committee report he himself commissioned because it failed to find anything deleterious about cannabis as medicine.

    Proof is in my hands though, as I possess a copy of the 1899 Merck’s Manual, where it describes Cannabis Tannate Merck, the medicine Merck made and patented and sold through pharmacies throughout the United States. The book lists over 30 indications known at that time, for which cannabis might be used. And not one death is said to have occurred directly from this substance.

    So we know the US government is lying to us, do we not? Excuse me, that was so blunt wasn’t it? But is there another way to describe the situation? Yes, cannabis CBD is the medicine that Charlotte Figi uses to reduce her daughter’s Dravet Syndrome epilepsy symptoms considerably, is that not proof? It reduces interocular pressure for those who use it to control their Glaucoma problems, is that not proof? Ever heard of RLS, Restless Leg Syndrome, well that’s another cannabis success story, if it’s proof you’re looking for.

    End of story, and at 80 it will be the end of me soon too, so I can get on my way….. 56 years of cannabis has helped me considerably, if I may be so bold to scream it out to the entire world. And believe me, at this age it’s painful to watch the congress of our so-called government, fumbling around waiting for their benefactors to tell them how to vote. What a disgrace this government is…….

  • Here is the reference to the IACM, the International Association of Cannabinoid Medicines, of Holland I believe, in which they describe the results of CBD cannabis medicine for epilepsy……. So how is it possible for the DEA to maintain cannabis in Schedule 1? This study was done in the USA.

    Science/Human: Cannabidiol effective against epilepsy in Dravet syndrome

    A clinical study with 120 children and young adults suffering from Dravet syndrome, which shows that CBD (cannabidiol) is effective in symptom control, was now published in the New England Journal of Medicine. Several centres across the USA participated in the placebo-controlled trial of 14 weeks of treatment.

    The median frequency of convulsive seizures per month decreased from 12.4 to 5.9 with CBD, as compared with a decrease from 14.9 to 14.1 with placebo. The percentage of patients who had at least a 50% reduction in convulsive-seizure frequency was 43% with CBD and 27% with placebo. The patient’s overall condition improved by at least one category on a standard scale in 62% of the CBD group as compared with 34% of the placebo group.

    Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017;376(21):2011-2020.

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