The pharmaceutical and biotech industry is tasked with one purpose: to improve the quality of life for people. But, what if that task were being compromised by the medicines they're creating?
Opioids have become a serious threat to patient well-being
Opioids are a commonly prescribed class of medicines that work with opioid receptors in the body to create a morphine-like effect that's often used to relieve severe and/or chronic pain. In terms of their clinical results, opioids have shown demonstrably positive impacts on reducing pain associated with a chronic disease, and they are a staple therapy for certain diseases. In 2012, some 259 million prescriptions were written for prescription opioids, which would be enough to ensure that every adult in the U.S. received their own bottle.
Unfortunately, this medicine designed to prevent chronic pain is also creating its fair share of pain for users and their families and friends. Opioids are a highly addictive therapy that, according to the American Society of Addiction Medicine, led to 20,101 overdose-related deaths in 2015.
In fact, the dangers of opioid addiction and overdose-related death have become such a reality that the Food and Drug Administration (FDA) recently requested Endo International take Opana ER, an opioid therapy, off the market. A review of the drug determined that its risks now outweighed its benefits. Said FDA Commissioner Scott Gottlieb, M.D.,
"We are facing an opioid epidemic – a public health crisis, and we must take all the necessary steps to reduce the scope of opioid misuse and abuse. We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse."
Are cannabinoids the solution?
There's little denying the growing evidence that opioid therapies present addiction, overdose, and overdose-related death risks. The real issue has been developing new therapies that could replace opioids without all of the adverse side effects while also providing the same pain-relieving effectiveness. Surprisingly, one substance that may have an opportunity to do just this is marijuana, or should I say the cannabinoids that drug developers are using from the cannabis plants.
Researchers have discovered that our bodies have natural cannabinoid receptors. These receptors, CB1 and CB2, may potentially hold the key to providing chronic pain relief for patients without the dangerous side effects of opioids. In particular, CB2 has been a focus of drug developers since it doesn't have the psychoactive side effects of cannabinoids that target the CB1 receptor.
But there's a bigger statistic at play here. While there have been reported incidences of people overdosing on marijuana, there were zero (I repeat 0!) overdose deaths related to marijuana in 2015. Recall, for comparison, that there were over 20,000 deaths due to overdosing on opioids in the same time period. If drugmakers can remove or limit the psychoactive impacts of cannabis on the central nervous system while still allowing the patient relief from his or her chronic pain, marijuana's cannabinoids would have a shot at unseating opioids as a primary chronic pain treatment.
Four marijuana stocks focused on cannabinoids and CB receptors for pain
Which drug developers are leading the charge on this possible transition away from opioids to cannabinoid-based therapies or therapies that target CB receptors? Let's take a look at four of them.
- Zynerba Pharmaceuticals (NASDAQ:ZYNE) -- Zynerba is an entirely clinical-stage drug developer with only two drugs in its pipeline, ZYN001 and ZYN002, which are targeting a total of five diseases. ZYN001, which is a tetrahydrocannabinol (THC) pro-drug patch, is aimed at treating fibromyalgia and peripheral neuropathic pain. It's also a drug that's only now moving into early stage studies. The allure of ZYN001, if it works, is that it's absorbed directly through the skin, thus avoiding first-pass liver metabolism, potentially even requiring a lower dose to achieve the desired efficacy of pain relief.
- Cara Therapeutics (NASDAQ:CARA) -- Cara Therapeutics' experimental product portfolio primarily revolves around kappa opioid receptor agonist CR845, but there's longer-term hope that CB receptor agonist CR701 could push opioids to the wayside. In preclinical rodent models, CR701 wound up reducing hyperalgesia (sensitization of nerve ending to painful stimuli) and allodynia (painful perception of innocuous stimuli) in a setting considered comparable to human conditions. For now, the best we can do is wait on Cara to outline its next steps for CR701.
- Axim Biotechnologies (NASDAQOTH:AXIM) -- Clinical-stage cannabinoid-based drug developer Axim has more than a dozen indications in its pipeline. Of particular note, the company's chewing gum delivery mechanism, MedChew-1401 for multiple sclerosis/pain spasticity, and CanQuit O, for opioid addiction, may offer hope for a move away from opioid use. Axim's chewing gum contains equal parts THC and cannabidiol, the non-psychoactive component of cannabis.
- Arena Pharmaceuticals (NASDAQ:ARNA) -- Arena, which may best be remembered for developing weight-loss drug Belviq, has shown promise with APD371, an oral Crohn's disease pain drug that targets the CB2 receptor. Initial safety and dose finding phase 1b studies found APD371 to be safe, leaving investors to wonder, similar to Cara Therapeutics' CR701, what's next?
Still a long way to go
Though cannabinoids and CB receptor drugs may offer plenty of hope, they're also a long way from their goal of pushing a potentially dangerous drug class out of the picture. As you can also see from the above four companies, none are really anywhere near commercializing their product. Axim has a potential cash shortage that could threaten its ability to run its clinical studies; Zynerba is just now moving into phase 1 studies; Arena's APD371 hasn't advanced recently; and Cara's CR701 hasn't moved beyond preclinical trials.
Beyond these therapies being very green behind the ears, the federal government could also provide a notable impediment to the industry. Since cannabis is a schedule I drug at the federal level and therefore has no recognized medical benefits, the DEA will probably take months, if not longer, to schedule any approved products. This delay provides even more time for opioid drugmakers to dig in their heels, or for a competing therapy to emerge.
Cannabinoid-based drugs and CB agonists also aren't going to be shown the red carpet if approved. Opioid drugmakers often have much deeper pocketbooks than these four companies, meaning competition and marketing could be a major challenge.
Don't get me wrong, it's every bit worth keeping your eye on the progress being made by marijuana stocks in fighting opioid addiction an overdose-related deaths, but a miracle medicine that replaces opioids simply isn't available at the flip of a switch – at least not yet.