How Do I Create a Pharmaceutical CBD Drug?

Currently, there is only one FDA-approved pharmaceutical CBD drug available on the market. Epidiolex is a prescription CBD drug that’s prescribed for rare forms of epilepsy. In order to create your own pharmaceutical CBD drug, you’ll have to go through the extensive steps provided by the FDA.

The FDA Drug Development Process for CBD Drugs

  • Step One: Discovery and Development
    • The discovery process can be accomplished in many different ways. Researchers can find new CBD drugs through:
      • New discoveries in a disease process that provides the opportunity to design a product to prevent or reverse the disease.
      • Numerous tests of molecular compounds to find potential beneficial effects from any disease.
      • Existing treatments that may have unanticipated effects.
      • New technology that enables different ways to target medical applications for specific areas in the body or manipulate genetic material.
    • When researchers decide to conduct further development on CBD, they must conduct experiments in order to find the following information:
      • How CBD is absorbed, distributed, metabolized, and excreted
      • The potential mechanisms of action as well as benefits
      • The right dosage
      • The best administration method (pill, injection, etc.)
      • Adverse events or side effects, also known as toxicity
      • How it impacts different demographics
      • How it interacts with other treatments and medication
      • Its effectiveness when compared to similar drugs
  • Step Two: Preclinical Research
    • Two forms of preclinical research must be completed before human studies can be conducted. These two types of preclinical research are In Vitro and In Vivo. The FDA requires that researchers utilize good laboratory practices defined in medical product development regulations. While preclinical studies don’t need to be very large, they have to provide detailed information on toxicity levels and dosage. When preclinical research is completed, researchers review this data and decide if they can proceed to clinical testing.
  • Step Three: Clinical Research
    • Clinical research is conducted on human subjects. As you develop a clinical study, you’ll need to consider what you want to accomplish for each of the phases found in Clinical Research Phases and start the Investigational New Drug Process.
    • Designing clinical trials:
      • Why qualifies
      • How many people will be in your study
      • How long will the study be
      • Choosing a control group or finding other wats to limit research bias
      • How the drug will be administered along with the dosage
      • What assessments will be studied as well as when or what data will be collected
      • How your data will be reviewed and analyzed
    • The Investigational New Drug (IND) Process:
      • You must submit an IND application to the FDA before you begin your clinical research. This application needs to include:
        • Animal study toxicity and data
        • Manufacturing information
        • Clinical protocols
        • Data from any existing human research
        • Information on the investigator
    • The FDA offers complimentary suggestions if you need any guidance during this process. However, you are not required to implement any of the advice provided by the FDA. The FDA has 30 days to review your original IND application, providing either an approval or a clinical hold. Clinical holds are rare– the FDA usually provides additional support to improve the quality of your clinical trial. The process continues until you decide to end your clinical trials or file a marketing application. You must have enough data compiled from two large, controlled clinical trials before submitting a marketing application.
  • Step Four: FDA Drug Review
    • Once you’ve compiled enough evidence from early tests, preclinical research, and clinical research, you can file a marketing application. The FDA must thoroughly examine all of your provided data on your CBD drug before making a decision to approve it or not.
    • New Drug Application (NDA):
      • The NDA is meant to demonstrate that your drug is safe and effective before its intended use can be studied. This is what you must include in your NDA:
        • Clinical results
        • Proposed labeling
        • Drug abuse information
        • Safety updates
        • Patent information
        • Any data from studies completed internationally
        • Institutional review board compliance information
        • Drug directions
    • If the FDA approves your CBD drug, they’ll work with you to develop and refine the prescribing information.
    • Sometimes the FDA will need you to address questions stemming from existing data. They may need additional studies before approval. You can decide if you’d like to continue further development or file a formal appeal if you disagree with their decision.
  • Step Five: FDA Post-Market Drug Safety Monitoring 
    • In order to ensure the safety and efficacy of your CBD drug, the FDA will monitor the product in the marketplace. They’ll review any reports of problems and can offer to add additional cautions for the dosage or usage information.

Work with the Nation’s Leading CBD Manufacturer

Hemp Depot is happy to share all the leading tips on starting a CBD business. If you’re interested in creating a pharmaceutical CBD drug, you’ll need to take all the proper steps in the FDA drug development process. For more information regarding pharmaceutical CBD drugs, please contact us!