Drugmakers are taking the first steps toward developing marijuana -based painkillers, as alternatives to the opioids that have led to widespread abuse and dependency.
Currently, marijuana (cannabis) is legal across 29 U.S. states, as well as in the District of Columbia. The cannabis plant has been used for decades to manage pain and there are increasingly sophisticated marijuana products available where it is legal.
Since there are no U.S. Food and Drug Administration (FDA)-approved painkillers derived from marijuana, companies such as Axim Biotechnologies Inc, Nemus Bioscience Inc and Intec Pharma Ltd are working to advance the alternatives drugs and are in various stages of development.
And there are more than 100 million reasons for them to pursue the project.
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.
According to the Centers for Disease Control and Prevention, opioid overdose, contributed to more than 33,000 deaths in 2015 alone.
For the first time, the FDA has called for the removal of an opioid painkiller for public health reasons. They asked Endo International Plc to withdraw its Opana ER painkiller from the market. 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, on record, there are no deaths related to marijuana overdose.
However, the new 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. Typically, drugs take at least a decade from discovery to approval.
Is it worth the wait?
Experts say an FDA-approved marijuana-based painkiller would ensure consistent dosing and potency, and availability across the country.
“Doctors like to be able to write a prescription and know that whatever they wrote is pure and from a blinded, placebo-controlled trial,” Said California-based Nemus’s CEO Brian Murphy.
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 pre-clinical 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.
There could soon be other alternatives as well. Pfizer Inc and Biogen Inc are among drugmakers developing non-opioid painkillers that are in advanced clinical studies.
Scientists continue looking for 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.
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 has proposed a drastic cut to the Medicaid budget and could gut, what advocates say, is essential coverage for drug addiction treatment, possibly hindering the fight against opioid abuse.