Ask-the-Expert: How will dsm-firmenich and OMG Pharma transform CBD drug delivery?

By:  Pharma Solutions Editors

 

Summary

  • dsm-firmenich has announced a new strategic collaboration with Australian-based biotech innovator in the cannabinoid medicines domain – Oz Medicann Group (OMG) Pharma. But what does this mean for cannabinoid-based therapies and patient care in the field?
  • We asked our resident experts – Athanasia Kanli, Global Market Development Manager Pharma and Zdravka Misic, Innovation Project Manager – about the details of the collaboration and why it could lead to a world-first cannabidiol (CBD)-based drug for insomnia.  
  • Read on to shed light on how dsm-firmenich and OMG Pharma are set to inspire a new era in CBD-based drug delivery.

In another landmark move, dsm-firmenich has announced a new strategic collaboration in the cannabinoid research and development space – this time with Oz Medicann Group (OMG) Pharma. Together, the companies are set to explore the therapeutic potential of cannabidiol (CBD)-based orally dispersible tablets (ODTs) to tackle insomnia head-on. 

The dynamic duo will harness dsm-firmenich’s high quality GMP CBD intermediate and cutting-edge formulation expertise and OMG Pharma’s pioneering research with a shared goal of transforming CBD drug delivery and, ultimately, patient convenience and treatment outcomes. But why now? Our in-house experts – Athanasia Kanli, Global Market Development Manager Pharma and Zdravka Misic, Innovation Project Manager – provide insights into dsm-firmenich’s participation in OMG Pharma’s eagerly anticipated insomnia research project, highlighting the collaboration’s potential to reshape the cannabinoid landscape and patient care.

1. Why is dsm-firmenich interested in ODTs for CBD drug delivery?

Orally dispersible tablets (ODTs) represent an innovative oral solid dosage form for CBD administration. Designed to dissolve quickly in the mouth without the need for water, they bypass first-pass metabolism (i.e., breakdown in the gut or liver), for rapid absorption of the active pharmaceutical ingredient (API). This makes ODTs an appealing and convenient drug delivery format for patients who have difficulty swallowing pills or tablets, like older adults. Moreover, their swift dissolution and absorption of the active ingredient(s) into the bloodstream makes ODTs particularly beneficial for health conditions requiring immediate effects, like insomnia and other sleep disorders. 

“As we know, CBD undergoes significant degradation during first-pass metabolism, up to 75%, limiting the amount of the drug reaching the bloodstream to exert its therapeutic effects1.  This is a key reason why CBD-based medicines have low oral bioavailability and why the molecule – and most other cannabinoids – are predominantly administered in liquid oil formats, which can be unpleasant for patients and lead to lower treatment regimen adherence,” says Athanasia Kanli. 

“To address this, there has been substantial innovation in the pharmaceutical arena to improve CBD’s bioavailability, reduce required doses and introduce more patient-friendly formats to the market. ODTs, including sublingual tablets, represent a significant advancement in this regard and open the door to more effective, patient-friendly treatments. They offer convenience, precise dosing and improved adherence, and given this, we see ODTs revolutionizing CBD-based therapies.”

2. Why is insomnia a focus area for dsm-firmenich and OMG Pharma?

Insomnia stands as a widespread global concern that profoundly impacts individuals' daily lives and overall wellbeing. Research indicates that insomnia affects somewhere between 10% to 30% of the global population2.  But despite being common and easy to diagnose, the condition remains difficult to treat. Many prescriptions and over-the-counter (OTC) insomnia medications demonstrate limited efficacy, side effects are common and dependency or tolerance can become an issue. But CBD could be the answer. 

“The endocannabinoid system, via which cannabinoids like CBD exert their effects, is a complex neurochemical network within the body that regulates various physiological functions, including sleep,” says Athanasia Kanli. “For this reason, the potential of CBD as a sleep aid has become a focus of research in recent years. Given that sleep disorders, like insomnia, remain largely unaddressed, CBD holds promise as a solution in this realm.” 

OMG Pharma has already conducted promising observational research in insomnia. In the next phase consisting of clinical trials, dsm-firmenich’s high quality GMP CBD intermediate will be used to further investigate OMG Pharma’s Schedule 3 OTC sublingual tablet. Planned for later this year, the trial aims to delve deeper into the bioavailability of the CBD-based sublingual tablet compared to other oral formulations in development – and ultimately inform the development of therapies that champion better patient care. 

 

3. How will your combined capabilities deliver a new generation of patient-focused therapies?

As well as leveraging dsm-firmenich’s trusted CBD intermediate for pharma research, the collaboration will harness the company’s leading-edge formulation capabilities, chiefly its bioavailability enhancement expertise, as well as its global regulatory experience and scientific insights. “We offer a robust cannabinoid portfolio that is trial-ready and of the highest quality. But we go beyond this to bring unique expert services to the table too,” Zdravka Misic explains. “The cannabinoid drug discovery and development market is intricate and constantly evolving. With our extensive global regulatory expertise and skilled technical and clinical teams, we’re helping OMG Pharma pioneer a novel CBD pharma formulation with enhanced absorption and patient convenience – and with confidence that it will be compliant in their market.” 

Commenting on why dsm-firmenich joined forces with OMG Pharma, Zdravka Misic says: “We decided to partner with OMG Pharma for several reasons, but primarily due to their team’s unwavering dedication to groundbreaking research in novel cannabinoid-based medicine, which perfectly complements our commitment to delivering science-driven solutions that address unmet patient needs. Together, we have the capabilities to push the boundaries of CBD pharma innovation and can’t wait to see where this journey takes us.”

The collaboration is powered by dsm-firmenich and Brains Bioceutical’s end-to-end innovation platform designed to help drug developers along the entire early-stage drug development journey.

4. What will this mean for dsm-firmenich customers?

CBD research is full of promise in the pharmaceutical industry, presenting numerous opportunities for groundbreaking developments in the space, and the chance to expand treatment options for patients globally. Yet, despite its potential, the market is still in its infancy and formulators face significant technical hurdles as they strive to innovate with these novel compounds. 

Choosing the right partner can empower manufacturers to realize the potential of cannabinoid-based pharmaceuticals and enter the market confidently and early, establishing a leading position. As a purpose-driven entity within the pharmaceutical realm, dsm-firmenich’s mission is to ensure every patient receives the care they deserve. We’re achieving this by driving forward the next frontier of medicine – one that’s powered by cannabinoids. 

Our collaboration with OMG Pharma represents the latest addition to our extensive network of collaborations in the cannabinoid arena, each strategically forged to elevate and broaden our offering. We understand that cannabinoid formulation is complex – and we know how to navigate it. What’s more, we are at the forefront of cannabinoid research, delving into the therapeutic potential of these molecules in areas like pain management, stress, anxiety and cancer

 

For more information, or to find out how dsm-firmenich is helping to develop purpose-led cannabinoid pharmaceuticals that enrich patients’ lives, visit: 

https://www.dsm.com/pharma/en/products/cannabinoid-actives.html

 

Published on

05 April 2024

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References

1. Perucca and Bialer. Critical aspects affecting cannabidiol oral bioavailability and metabolic elimination, and related clinical implications. Cannabinoids in Neurology and Psychiatry, 2020.

2. Bhaskar et al. Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. J Family Med Prim Care, vol. 5, no. 4, pg. 780-784, 2016.