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The Challenges and Barriers to CBD Obtaining FDA Approval

Leaf Vertical > Blog > The Challenges and Barriers to CBD Obtaining FDA Approval

A growing number of clinical studies indicate that cannabis or single cannabinoids (CDB) may have medicinal value for certain diseases. Between 1975 and the present, at least 110 controlled clinical studies have been published, assessing well over 6,100 patients suffering from a wide range of conditions.” – Project CBD

Medicinal cannabis is now available on prescription in Austria, Canada, the Czech Republic, Finland, Germany, Israel, Italy, the Netherlands, Portugal and Spain. Doctors in the USA can issue ‘recommendations’ rather than prescriptions. 34 states and the District of Columbia now have some form of medicinal cannabis access.

In the United States, and abroad, there is a need for more scientific research on cannabinoids for cancer patients. But, studying CBD is not easy: Scientists complain that laws and regulations put excessive constraints on their work. Currently, CBD is classified by the federal government as a Schedule 1 drug. A drug with this classification means it has high potential for abuse and no accepted medical use. As a result, scientists who study the compound must follow a host of restrictive rules.

The new 2018 Farm Bill, if passed may alleviate some of the barriers of CBD research and development in terms of legal issues as the new legislation sets to legalize hemp, the plant from which CBD is derived.

How Expensive Are Clinical Trials  
Laws and regulations aside, research is quickly ramping up for more CBD clinical trials; however, the successful clinical development of a drug, from preclinical testing to marketing approval, requires a large amount of resources and money.

Running a clinical trial is a major portion of the development cost of a drug. According to clininicalresearch.io, each patient in a clinical trial costs approximately $36,500. The total costs of a typical drug trial can escalate to $5-$50 million for a Phase 1 trial and up to $50-750 million for a Phase 3 trial. The estimated development cost of a single drug is $2.6 billion, but can run upwards of $12 billion.

Barriers to FDA New Drug Application  
While money and resources aren’t the only things needed to get a new drug on the market in the United States. Special authorization by the FDA needs to be granted before any company can make and market a drug in the U.S., even a generic pharmaceutical drug. While the application process is called the Abbreviated New Drug Application, or ANDA, the process is hardly abbreviated and the average time for a decision is 17 months.

Failing From the Start
In the first review of an application, approximately 93% of applications are rejected. Of those that are re-submitted and reviewed for the second time, 66% are once again, not approved. The FDA usually approves only about one in ten clinically tested drugs. Additionally, to get from preclinical studies through all three phases of clinical trials and then to be approved for prescription, it can take up to 10 years. Even if a startup company had the capital resources to develop and test the drug according to FDA rules, it still might not receive revenue for 10 years.

Failing to Reach the Finish Line
In one of the largest studies on biopharmaceutical clinical development success rates, more than 7,400 drug programs by 1,103 companies found that the Food and Drug Administration ultimately approved less than one of every 10 drugs that enter clinical trials.

 About Leaf Vertical, Inc.
Leaf Vertical Inc. is an innovative, clinical-stage biopharmaceutical research company, committed to discovering and developing novel therapeutics from its proprietary cannabinoid product platform.

For more information on Leaf Vertical or its Cannabinoid (CBD) clinical trials, use in the treatment of specific types of malignancies related to glioblastoma, myeloma, gastrointestinal, and breast cancer, when administered in conjunction with Standard of Care, please contact Leaf Vertical by phone at 407-776-9217 or visit the company’s headquarters at 805 S. Kirkman Rd, Suite 202, Orlando, Florida 32811.

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