Marijuana for Pain Management: FDA drug approval could increase the research
The United States has been grappling with pain management drugs that contain opioids for quite a while. Multiple studies and court rulings indicate opioids in these drugs make millions addicted. Moreover, nine hundred people die every week due to overdose of opioids.
The US-based pharma company ”Purdue Pharma”, which was held responsible for fuelling the opioid crisis, filed bankruptcy protection in September this year as part of its efforts to deal with thousands of lawsuits waged against the company.
Most of the lawsuits claimed that Purdue and its owners, the billionaire Sackler family, had aggressively marketed the prescription painkiller OxyContin, while at the same time misleading doctors and patients over addiction and overdose risks.
On an additional note, a similar threat is building over Europe as well, though the situation is not as worse as in the US. Quartz, in an article, mentioned that Mundi Pharma, another company owned by the Sackler family is using the same strategy to sell opioid-based drugs overseas. Mundi Pharma is active in more than 30 countries in Europe.
According to research, in Europe, about 1 in every 5 adults suffer from chronic pain. However, its rate of prescription drug abuse is higher when compared to the US. In fact, in 2015, there were 8441 overdose-related deaths in Europe. The number, however, is nothing when compared to the US where 62,000 people died due to overdose in 2016.
As of now, the U.S. Drug Enforcement Administration (DEA) considers marijuana as a Schedule I drug, on the same level as heroin, LSD, and ecstasy and likely to be abused and lacking in medical value. However, the research for medical marijuana is blooming.
Legalized cannabis is changing the healthcare industry and medical marijuana has become a hot topic especially after FDA approved Epidiolex, the first drug that comprises an active ingredient derived from marijuana, to treat rare, and severe forms of epilepsy.
The medical marijuana market is witnessing tremendous expansion as the amount of scientific literature supporting its benefits in the treatment of diseases like Seizures, Cancer, Parkinson’s disease, muscle spasms, chronic pain, et cetera.
Considering all the above factors, pharmaceutical and biotech companies are seeing a strong growth trajectory in the Medical marijuana industry. Another or perhaps the main reason behind this being that medical marijuana has become a potent alternative for opioids for which pharma companies were looking for an alternative since long.
Further, notable universities are researching the use of Cannabis as a pain management drug. The University of Oxford is set to spend £10 million in a research program of treating pain. Other notable universities researching medical marijuana are the University of Colorado Denver and McGill University. We will be discussing in brief about their research in the latter part of the article.
We will also discuss the leading startups and universities that are working on the application area of cannabis as a pain management drug. Succinctly put, this report will help you get answers to key questions like:
- Who are leading players from the pharma domain in the medical marijuana for pain relief domain?
- Which new cannabis-based companies are innovating exclusively?
- Which universities are leading in research for medical marijuana for pain relief?
- The notable collaborations in medical marijuana for pain relief domain.
You could use the TOC below to jump to the particular section of your interest.
Market Share of Medical Marijuana in the Treatment of Different Diseases
Pain management, nausea, muscle spasm, etc. are areas where cannabis finds an application in the pharma sector. The exhibit below shows which application areas are gaining popularity in the market, and a future prediction of these market shares. We can see that pain management is a highly focused area in the medical cannabis domain.
According to the World Health Organization (WHO), cancer was responsible for about 8.8 million deaths in 2015. To reduce the burden of chronic pain of chemotherapy, medical marijuana has become an increasingly widespread alternative to traditional pain-relieving opioids which have lethal side-effects.
Below are some other advantages associated with the use of cannabis for medical purposes that will augment the medical marijuana pain management market growth.
- Medical cannabis is declared as a potent product for chronic pain management.
- There are zero documented overdose-related deaths from cannabis in 2016 whereas in 2015 there were 20000 prescription opioid overdose deaths.
- Demand for pain management is more as recent estimation by the National Health Interview Survey (NHIS) shows, around 25 million people suffer from pain daily in the US.
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Leading Pharma Companies Working on Applications of Marijuana for Pain Management
Cara Therapeutics, a clinical-stage biotechnology company develops drugs for the treatment of pruritus and acute and chronic pain. Its drug development pipeline isn’t entirely devoted to cannabinoid or endocannabinoid-mimetic drugs. In actuality, Cara Therapeutics was almost exclusively focused on developing CR845, a kappa-opioid receptor agonist (KORA). The opioid is an ideal candidate to treat pain (and pruritus) but also has side effects like nausea, sedation, depression, and addiction.
Cara’s ties to cannabis preface to its preclinical research involving CR701, which is a cannabinoid receptor agonist it designed for chronic pain treatment.
Cara therapeutics product pipeline includes both opioid and cannabinoid drugs. However, the CB agonist CR701 that makes it eligible for this list is still in its pre-clinical trial phase and a lot rides on the outcome of the trials before the stock could get a high from marijuana.
Top innovations by CARA Therapeutics
- Cara is working on the development of lead molecules which can selectively modulate peripheral CB receptors without targeting CNS cannabinoid receptors. Peripheral CB receptor modulators will be initially developed as a novel therapeutic approach for neuropathic pain, a condition currently without consistently effective therapies.
- Cara’s most advanced CB compound, CR701 – which has been evaluated in a rodent model of neuropathic pain that produces both hyperalgesia (sensitization of nerve endings to painful stimuli) and allodynia (painful perception of innocuous stimuli) – is comparable to human conditions and is now in preclinical development.
- CA2691776C – Cara Therapeutics filed a patent on the preparation of substituted imidazoheterocyclic compounds, which acts on peripheral present Cannabinoid receptors to treat pain.
GW Pharmaceuticals is renowned as the leader in the development and commercialization of cannabinoid prescription medicines. Their cannabis-derived drug EPIDIOLEX® is the first to be available with a prescription in the US. EPIDIOLEX®is an oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients of above 2 years.
Epidiolex contains cannabidiol(CBD) which is increasingly popular for its reported abilities to deliver relief from maladies such as anxiety, joint pain, insomnia, and nausea. There’s also a good chance it will be prescribed for off-label use.
The company is also performing a study to evaluate the effects of cannabis-based medicine in patients with pain of neurological origin. Clinical trials have reached phase 3 level successfully.
Top innovations by GW Pharmaceuticals
GW Pharmaceuticals is making significant advancements in oncology research and development. They seem quite keen to protect their technology as well. They have filed multiple patents for cannabis pain management solutions. They are one of the top patent holders in the medical cannabis sector. Some of their prominent patents are as follows:
US20080139667A1 – It focuses on the use of cannabinoids for the treatment of pain, inflammation in arthritis. The cannabinoids can be cannabidiol (CBD) or cannabidivarin (CBDV) and delta-9-tetrahydrocannabinol (THC) or tetrahydrocannabivarin (THCV).
US9895342B2 – This patent is related to cannabinoids (cannabigerol, cannabichromene, cannabidivarin or tetrahydrocannabivarin) for use in the treatment of neuropathic pain. Phytocannabinoids are isolated and/or purified from cannabis plant extracts.
Trait Biosciences, a cannabis biotechnology research company produce water-soluble and natural cannabinoids which increase bioavailability. They are using glycosylation, which mimics what the body does when it metabolizes cannabis by attaching a glucose molecule to the substance. This patent-pending technology, currently being tested on humans in clinical trials in Israel, improves onset time and avoids the “salad-dressing effect,” where the oily cannabis compounds separate from water.
The company has also filed a patent for a second process that binds the cannabis compounds to water-soluble proteins rather than glucose molecules (WO2018176055A2).
Trait’s Producer Division is also working with ultrahigh yield “Super Producer” cannabis plants that can generate dramatically greater yields and RNAi plant protection technologies that reduce the accumulation of toxins in cannabis plants without the need for pesticides or fungicides.
Leading Universities Researching Applications of Marijuana for Pain Management
Oxford University: £10 million research program on medical cannabis for treating pain
Oxford University is set to launch a £10 million research program on medical cannabis for treating pain. They will be investigating the role of cannabis medicines in treating pain, cancer, and inflammatory diseases. The program is being financially backed by private equity firm Kingsley Capital Partners, who invested the money in the hope of creating an international hub for cannabinoid research.
“We have endogenous cannabinoids in our system that modulate the way in which our synapses operate. They’re really important, they’re pervasive throughout our brain and our immune system, and therefore that’s a fantastic therapeutic opportunity for us. If we can understand better how we can achieve the beneficial effects of cannabinoids while we’re avoiding some of the harmful effects then that potentially could change the way we practice medicine”
Zameel Cader, Associate professor for Clinical Neuroscience, Oxford University
University of Colorado: Conducted a study that tests the effects of cannabinoid levels in blood on pain relief
The University of Colorado, Denver and Colorado State University is conducting a study that tests the effects of cannabinoid levels in blood on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use edible cannabis.
Over two weeks, participants use an edible product of their choice. Blood levels of 9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) are measured before, during, and after the two-week exposure period to determine whether or not there was any association with pain, physical activity, anxiety/depression, inflammation, sleep, and cognitive dysfunction.
McGill University: How CBD can be used as medicine without the dangerous side effects of the THC?
Research Institute of the McGill University Health Centre (MUHC) and McGill University have delivered a piece of news for chronic pain sufferers by highlighting the effective dose of marijuana plant extract cannabidiol (CBD) for safe pain relief without having any psychoactive component or euphoria produced by the THC.
Dr. Gobbi, who is also Professor of Psychiatry at the Faculty of Medicine at McGill University and staff psychiatrist at the MUHC sees this as advancement for the evidence-based application of cannabis in medicine with CBD offering a safe alternative to THC and opioids for chronic pain, such as back pain, sciatica, diabetic, cancer and post-trauma pain.
Dr. Gobbi quipped, “Our findings elucidate the mechanism of action of CBD and show that it can be used as medicine without the dangerous side effects of the THC”. This research is a new advancement for an evidence-based application of cannabis in medicine.
Noticeable collaborations in medical marijuana pain relief domain
Oxford University: Cannabinoid biomedicine research program launched
Oxford University announced its partnership with a private equity company, Kingsley Capital Partners, for developing novel cannabis treatments for pain, cancer and inflammatory diseases. These research studies will result in several product approvals for various medical conditions and hence can have a positive impact on the medical marijuana market growth.
Oxford and Kingsley also hosted an International Cannabinoid Biomedicine Conference, which was designed to increase dialogue in the cannabinoid research space, the first of which took place in Q4 2017.
Gw pharmaceuticals Partners with Otsuka pharmaceuticals announced a research collaboration agreement for Cannabis Research
In February 2007, GW pharmaceuticals and Otsuka pharmaceuticals announced a research collaboration agreement followed with a strategic cannabinoid alliance, which gave Otsuka exclusive rights to develop and market Sativex in the US. The companies will jointly oversee clinical development and regulatory activities in the US.
The research collaboration on cannabinoid has an initial term of three years, during which Otsuka made available a research fund of $9 million, which is being used for covering research activities carried out by its scientific collaborators and GW Pharmaceuticals.
Tree of Knowledge International Corp. sponsors $350,000 Research Project for its Innovative Enhanced Delivery Technology
On January 30, 2019, Tree of Knowledge International announced that they have entered into a Sponsored Research Agreement with Ryerson University, Toronto, Canada. The purpose of this agreement is to conduct additional research on the company’s innovative ultrasound technology in addition to novel nanotechnology delivery methods. This research will enhance the efficacy of medical Cannabis and Cannabidiol (CBD) derived therapeutics.
WeedMD Partners with the World-Renown Technion-Israel Institute of Technology for Cannabis Research
WeedMD, a licensed Canadian medical marijuana producer, announced its partnership with the cannabis database project controlled by the Technion-Israel Institute of Technology (TIT). The collaborative entity would research cannabinoid and terpenoid profiles of 25 of WeedMD’s cannabis strains.
WeedMD will submit 25 of its strains for inclusion in the Cannabis Data Project, which maps strains and their efficacy in treating certain medical conditions. As there are only a limited number of Dealer’s Licenses amongst the 90 Licensed Producers in Canada, securing this license is a critical step in advancing WeedMD’s medical and recreational growth strategies. The company will work both independently and with research institutions to accelerate innovation related to cannabinoid applications and delivery systems. This partnership will also help them make their position in the global cannabis market.
The opioid crisis is a bad chapter in pharmacological pain management, and patients are demanding a paradigm shift. If patients are in pain, they want to avoid taking opioids.
While it could be too early to be referred to as a silver bullet, cannabinoids applications in pain management are stellar as it can inhibit pain in a large range of experimental pain paradigm. Its applications in pain management are the forerunner of effective precision pain medicines that are free from opioids, and the danger of overdose.
Added the approval of FDA for Epidiolex, which is another big positive sign, universities, Upstarts, and some popular pharmaceutical companies have started employing new methodologies and strategies to extract the sought after therapeutic effect of cannabis like in management of pain.
The future is going to likely see a growing number of cannabis-based pain relievers and cannabis-based drugs with other therapeutic effects, a growing competition, a growing number of patents on cannabis-based drugs, and drug patent wars.
The legislatures across the globe have started liberalizing laws related to medical marijuana. This is going to add fuel to the fire of growing competition in the medical cannabis market which is forecasted to reach 44.4 Billion USD by 2024.
For the organizations working in the area of pain management, this is a crucial time that is going to determine the market leaders for the upcoming decade. Effective R&D collaborations, patent watch, and competitive analysis that combine market and technological research are certainly a way forward for an organization to have a strong foothold and bigger market share.
Authored by: Rajneesh Rana, Research Analyst, Market Research and Gaurav Sharma, Associate, Solutions.