High hopes ride on marijuana painkillers amid opioid crisis

Skye Bioscience

23/06/2017 15:24

By Natalie Grover 
    June 23 (Reuters) - 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  AXIM.PK , Nemus Bioscience Inc 
 NMUS.PK  and Intec Pharma Ltd  NTEC.TA  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 
 ENDP.O  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. 
 urn:newsml:reuters.com:*:nL1N1J522Z 
     
    FIGHTING THE EPIDEMIC 
    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.(http://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.  
     
    OTHER OPTIONS 
    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 
 PFE.N  and Biogen Inc  BIIB.O  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. 
 urn:newsml:reuters.com:*:nL1N1JJ0F3 
     
 
 (Reporting by Natalie Grover in Bengaluru; Editing by Sayantani 
Ghosh and Sriraj Kalluvila) 
 ((natalie.grover@thomsonreuters.com;)(within U.S. +1 646 223 
8780, outside U.S. +91 99 1694 7070; Reuters 
Messaging:natalie.grover.thomsonreuters.com@reuters.net)) 
 
Keywords: MARIJUANA FDA/