Chemistry Medical Research

FDA Grants Cannabis-Based Drug (Caflanone) Orphan Status

Written by Lydia Kariuki

Pancreatic cancer causes nearly 7% of all cancer deaths in the U.S. The prognosis depends on the stage of the cancer at diagnosis. Unfortunately, most cases are caught when the cancer has advanced, leading to a poor prognosis and a 5-year survival rate of only 8%. [1]

Researchers have been looking into different approaches to slow tumor progression in pancreatic cancer. Cannabis-based therapies have been an area of interest for researchers as some cannabis compounds have shown anti-tumor effects in pre-clinical studies.

Recently, a drug company by the name of Flavocure was granted orphan drug status for flavonoid-based drug caflonone (FBL-03). Pre-clinical studies conducted at Harvard Medical School demonstrated powerful results in difficult-to-treat animal models of pancreatic cancer. [1] This has led to optimism in both the medical research and patient communities.


Flavonoid FBL-03G

Caflanone, aka FBL-03G, is derived from a flavonoid-rich Cannabis sativa cultivar that is endemic to Jamaica. The research team created a synthetic version of the bioactive material which is currently available commercially for clinical research.

Flavocure CEO Dr. Ngeh Toyang highlighted that while less than 200,000 are diagnosed with pancreatic cancer in the U.S. each year, pancreatic cancer is the third leading cause of cancer deaths.


Orphan Drug Designation

The Orphan designation granted to Caflanone was imposed by the Orphan Drug Act of 1983, under President Ronald Reagan’s tenure. This grants certain rights and privileges to drug companies across the different stages of drug development. Drugs granted this designation target rare and difficult-to-treat diseases affecting less than 200,000 people annually in the U.S.

Flavocure Executive Chairman Dr. Henry Lowe remarked that that this was a significant milestone for the company, which is committed to successful innovations in drug development. He concluded by saying the following:

“The world requires and demands a new standard of care that is both effective and novel for the treatment of this disease. As a recognised leader in this field of drug discovery, we are poised to bring this new standard of care to the world.”

The company is planning to commence human trials in the coming months now that they have been greenlighted by the FDA.

The preclinical study was carried out by Flavocure in partnership with Harvard Medical School, and the open-access results were published in the Frontiers in Oncology Journal. The researchers implemented a sustained nano-drone delivery system and confirmed “potential for this new cannabis derivative in the treatment of both localized and advanced pancreatic cancer.” [1]


Image Source

NickyPe via Pixabay



  1. Moreau M, et al. Flavonoid derivative of cannabis demonstrates therapeutic potential in preclinical models of metastatic pancreatic cancer. Frontiers in Oncology. 2019;9:660. [Impact Factor: 6.224; Times Cited: 14 (Semantic Scholar)]

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Lydia Kariuki

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