FDA Report On Its 50 Years In Cannabis Research, Signals A Boost In Medical Marijuana Prospects

Researchers with the Food and Drug Administration (FDA) reported Wednesday on the agency’s 50 years of experience with marijuana research. In an article titled “FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development”, the authors summarize a recent FDA report published in Open Exploration. In short, the FDA researchers and article authors, Cassandra Taylor and Schuyler Pruyn present a breakdown of cannabis and cannabis-derived products (CCDP) applications that the agency has received over.

The document comes some two months after Health and Human Services (HHS) Secretary Xavier Becerra confirmed his agency has recommended cannabis should be rescheduled.

Per the report, since the early 1970s, the agency obtained more than 800 investigational new drug drug applications (INDs), and pre-investigational new drug applications (pre-INDs) related to CCDP.

“Over the last 10 years, there has been increased interest in studying CCDPs as medical treatment options,” the article reads. “We have received double the number of IND and pre-IND applications during this time.”

The authors highlight that the article also helps the agency bust the myths around the types of CCDP research the FDA has reviewed over the years, and that it can help researchers with developing their own CCDP clinical research programs.

Key Highlights

• When researchers submit INDs or pre-INDs for CCDPs to the Center for Drug Evaluation and Research (CDER), CDER reviews it like any other product that would be regulated as a drug. 

• Currently, the FDA is reviewing more than 150 active INDs that evaluate CCDPs, including related synthetics (human-made chemicals that produce similar effects as naturally occurring substances).

• To date, the FDA has not approved a marketing drug application for cannabis to treat a disease or condition. However, it has approved one medicine that contains a naturally occurring cannabis compound – Epidiolex. The FDA approved Jazz Pharmaceuticals JAZZ Epidiolex is a CBD-based drug for treating children with severe forms of epilepsy. FDA is reviewing clinical research on CCDPs that include a complex mixture of compounds, which is different when compared to the single molecule formulation of Epidiolex (CBD).

• The clinical trials under the majority of CCDP INDs focus on four therapeutic areas: addiction and pain medicine- 53%, neurology- 19%, immunology and inflammation- 14%, and psychiatry- 9%.

• The agency continues to support scientific research needs to develop new marijuana-based drugs, therefore it has published two guidance documents: Botanical Drug Development in 2016, and Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research in 2023. 

See Also: FDA Presents Potential Framework For CBD, From Edibles To Delta-8, Reaffirms Congress Is In Charge

The FDA predicts there will be an increase in INDs evaluating CCDPs. “We also expect to see new, innovative products for evaluation under INDs,” the authors wrote. “This may include the use of newly identified or less common cannabinoids, as well as other components of the cannabis plant, such as terpenes (naturally occurring chemicals found in plants). Researchers may also begin to expand on their use of edible CCDP product types, as well as investigate new ROAs.”

DEA Calls For Production Of 900.6K Grams Of Delta-9 THC For Research 

Meanwhile, the Drug Enforcement Administration called this week for the production of 900,610 grams of delta-9 THC and 790,010 grams of all other tetrahydrocannabinol for the purpose of research in 2024. The news comes several days after, the DEA already increased the 2023 quota for delta-9 THC to 628,460 grams and called for 350,000 grams of other tetrahydrocannabinol.

The huge increase in production of all other tetrahydrocannabinol could be because of the rising interest in some isomers like delta-8 THC and delta-10-THC, writes Marijuana Moment. 

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