Cannabinoids in pharma series: the future prospects of cannabinoids

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Posted: 27 August 2019 | Victoria Rees (European Pharmaceutical Review) |

This series investigates cannabinoids and pharmaceutical interest with industry experts explaining the position of the ingredient. In this third piece, we discuss the future of the cannabinoid industry and how it will grow within the realm of pharmaceuticals.

Despite the developments of medical uses for cannabinoids within the pharmaceutical industry, there is still much research needed into the active ingredient. Uptake has been limited, as discussed in our first and second articles, but there is still potential for growth. Here, we investigate how cannabinoids are likely to develop and progress in the future.

European Pharmaceutical Review’s Victoria Rees talked to Alex Wasyl, CEO of Nexien BioPharma (NXEN), Dr Guy Chamberland, CEO and CSO of Tetra Bio-Pharma (TBP) and Anthony Kievid, Director of Business Development at Echo Pharmaceuticals (ECHO) to learn more about how cannabinoids may evolve.

How the industry will likely change

The industry experts all agree that pharmaceutical cannabinoids will experience growth in the future. However, this may not be seen immediately.

Wasyl says that in the US, the pharmaceutical market could face difficulties. For example, he predicts that the US Food and Drug Administration (FDA) will encounter problems with products that make health claims through the medical marijuana framework without sufficient evidence.

He adds that currently, the quality control required for such products is not present. Indeed, certain cannabinoid brands were recently found to have products containing very little cannabidiol (CBD) compared to their label claim. Therefore, the future of cannabinoids on the market will need to have further quality control to ensure patient safety.

Dr Chamberland explains that many cannabis companies are failing to conduct randomised, blinded controlled trials. This limitation within the clinical research process results in bias and uncertainty surrounding the results, he says, as the effects may be from a placebo-effect, therefore making these trials unreliable. He argues that better research is needed from companies in order to induce worthwhile change in the industry.

Kievid says that a few medicines containing tetrahydrocannabinol (THC), a synthetic compound analogous to THC, or even a combination of CBD and THC, are available already. However, he predicts that more products will be approved soon, expanding the industry further.

Growth of the cannabinoid market

The experts say that the pharmaceutical cannabinoid industry has the potential to become a booming market as they develop in the future. Wasyl believes that cannabinoids will become a large-scale industry due to growing perceptions that cannabinoids are a “cure-all” for illnesses. He thinks many people will invest in the industry, including those who know little about it, but this will only accelerate its growth.

…many people will invest in the industry, including those who know little about it, but this will only accelerate its growth”

Dr Chamberland says that currently, some of the psychoactive cannabinoids make them analogous to opioids in certain respects, which will guide the way that new products are prescribed. Regulators are learning from the current “opioid crisis” in the US and some parts of Canada which could impose strict abuse deterrence requirements. He says that legislation should be in place before widespread availability of cannabinoids. He argues that opioids still work well when used appropriately but their use is currently debated due to abuse and overdosing. Dr Chamberland also sees cannabinoids being introduced as adjuncts to treatments, which may allow use of lower doses or even less opioids for patients with chronic pain.

Kievid explains cannabinoids current share on the market is limited, but this could soon change dramatically. However, this will depend on pricing of cannabinoid products, which could affect the accessibility of obtaining the drugs.

“The CBD product that is now approved in the US is doing quite well and the same could happen in Europe,” he predicts. “It would drastically change the market perspectives.”

Developments for the future

Pharmaceutical companies are continuing to research cannabinoids and their uses. Nexien BioPharma, for example, has one granted patent and seven pending patents in total. Wasyl says that the indication they are focused on currently is myotonic dystrophy and myotonia and they are very close to a pre-investigational new drug (IND) meeting with the FDA.

…patients may need to be monitored carefully when they are on other medications”

He relays that Nexien is also looking at parenteral formulations and parenteral delivery systems due to the complications of absorbing the drug orally. “Some people will metabolise THC into 11-Hydroxy-THC more readily than others,” he explains. “Because 11-Hydroxy-THC is more potent on a milligram per milligram basis, there can be variations in side effect profiles. Also, patients may need to be monitored carefully when they are on other medications because cannabidiol is a cytochrome p450 inhibitor – the enzyme complex in the liver that is responsible for metabolising most drugs.”

Dr Chamberland explains that one of Tetra Bio-Pharma’s priorities is targeting advanced cancer pain. He states that they have had a pre-IND meeting with the FDA where the programme was essentially validated. The advanced cancer product is in its last phase of development and the company recently completed another pre-IND meeting for its ophthalmic programme. “Now we’re finalising what we need to enter a clinical trial in painful dry eye.” He says there are a lot of “unmet medical needs” relating to pain conditions including the eye.

Other developments for the company include working on interstitial cystitis, fibromyalgia and opioid reduction. He notes they have “strong intellectual property for their product portfolio and for their various delivery systems.”

Kievid says that Echo Pharmaceuticals cover the whole value chain apart from growing the cannabinoid plants. Their patents include a cannabinoid dry power granular formulation suitable for oral administration within a tablet containing THC, CBD and other cannabinoids. Echo has currently performed 10 clinical trials and has others in the pipeline.

He remarks that using tablets that include pure THC or pure CBD are more patient friendly, elegant and efficient solutions with higher bioavailability than other formulations of medicinal cannabis, including smoking.

Conclusion

There are many opportunities that cannabinoids present on the market, but these are not without complications. Despite this, the future still looks bright for the cannabinoid industry which, according to our experts, is set to grow.