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As more states approve the use of medical marijuana-and its rising profile as potential opioid alternative-industry and FDA are stepping up their focus on developing cannabis-derived therapies.
Over the years of being a business-to-business editor, I’ve stayed far away from press releases around marijuana and cannabis, for reasons of professionalism or credibility. (Also, because of the propensity for kitschy headlines). But in this month’s article reviewing the media mentions around pharma, the authors note “another area where pharma can take a leadership role is the legalization of medical marijuana.
Legalization will have an impact on the sale of drugs for which marijuana is an alternative, especially for the Medicare population. Pharma is at risk of lost sales as more states approve the use of marijuana for medical purposes.” So what’s under the covers with cannabis?
FDA has many responsibilities around cannabis outside of drug development. But under its drug purview, it actively supports development of drugs from marijuana. “From” being the key word: the agency hasn’t yet approved a marketing application for a drug product containing or derived from botanical marijuana…the actual plant. The drugs that have been approved to date are synthetic forms of cannabidiol (CBD) and tetrahydrocannabinol (THC). THC is the major psychoactive ingredient in marijuana, and CBD is a compound that counteracts the psychoactivity of THC, while offering relief from inflammation, pain, anxiety, and more, without the sleepiness or unease associated with marijuana.
FDA also offers a guidance on the use of botanicals (e.g., marijuana) as sources for drugs, quality manufacturing, activities, and applies expedited approvals, as with other drugs, using orphan disease designation, priority review, and fast-track designation. According to FDA’s Marijuana Q&A web page, updated at the end of June, the agency has approved Marinol and Syndros-which include the active ingredient dronabinol, or synthetic THC-for therapeutic uses in the U.S., including the treatment of anorexia associated with weight loss in AIDS patients. FDA also approved Cesamet, containing the active ingredient nabilone, synthetically derived and chemically similar to THC, for the treatment of severe nausea and vomiting caused by cancer chemotherapy.
Current examples in the pipeline for cannabis include GW Pharmaceuticals’ lead cannabinoid product candidate Epidiolex. This proprietary oral solution of plant-derived CBD is in development for severe, orphan, early-onset, treatment-resistant epilepsy syndromes, including Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, and infantile spasms (IS). The company has an FDA expanded access program in place for Epidiolex. Corbus Pharmaceuticals’ lead product candidate, Anabasum, is a novel synthetic oral endocannabinoid-mimetic in Phase II trials for reduction of chronic inflammation and fibrotic processes. INSYS Therapeutics is also investigating CBD for IS.
One of the main reasons for pot’s popularity is the search for opioid replacements in pain management. As the pressure on pharma to address its role in the opioid epidemic increases, the industry, physicians, and science are actively seeking alternatives for patients. While it was also mentioned that pharma could take a leadership role in the legalization of medical marijuana based on its expertise with the manufacture and distribution of controlled substances, the following statistics need to be examined.
Currently, eight states have legalized recreational cannabis and 29 states allow cannabis for medical use. According to New Frontier Data, both the recreational cannabis and medical use cannabis markets are expected to grow and in 2025 will represent $10.9 billion and $13.3 billion respectively.
Conducting a clinical trial with cannabis is not that much different, save that your investigator will need a license from the DEA and clinical trial supplies need to come from qualified sources, with recent reports indicating shortages in that area.
The percentage of people who conceivably could use medical marijuana as an alternative to a prescription cannabis-derived drug should be weighed. However, this is also part of what pharma is experiencing anyway in regard to its drugs, differentiating outcomes in the market. In this case, for example, FDA doesn’t examine actual marijuana because it can’t quantify the quality of the plant. Synthetically-derived compounds are consistent and can lend credence to the data. Additionally, FDA approves drugs that meet safety and efficacy rquirements in clinical trials, which still means something to physicians and patients in search of cures, symptom management, or improved quality of life.