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A Deeper Look at FDA Approval and the Clinical Trial Process

An explainer to help you follow your favorite psychedelic medicine through the FDA and clinical trial process
The post A Deeper Look at FDA Approval and…



The Food and Drug Administration (FDA) might not be the first thing you think of when delving into the world of psychedelic medicine. However, this governmental body plays a pivotal role in the process of bringing new treatments from the research phase to the marketplace. The FDA serves as a gatekeeper, ensuring the safety and efficacy of drugs, from common pain relievers to groundbreaking psychedelic therapies.

But what’s an “IND”? What’s the difference between Phase 2A and 2B? And what are the odds of a drug actually making it through trials and into the market?

Here’s an explainer to help you follow your favorite psychedelic medicine through the clinical trial process.


Early Stages of Drug Development

Getting a new drug to market is a long and rigorous process. Regulatory entities like the FDA and Health Canada have created a system of progressive stages, each designed to run candidate drugs through established scientific measures to ensure they are safe and effective.

The process begins with the drug’s preclinical testing, primarily conducted in laboratories and on animals, to determine its potential effectiveness and to evaluate any apparent risks.

Firms seeking to get their drug approved by the FDA for commercial sales need to complete five steps: discovery & development, preclinical research, clinical research, review, and post-market safety monitoring.

The early stages (discovery & development) are a time of both innovative thinking and strict standards. Fresh insights into how a disease works, or novel ways of using a compound, can inspire ideas for new treatment methods. Companies theorize on new ways to treat conditions, using both new and existing molecules (think psychedelic medicine R&D).

Most of this is done in test tubes, confirming that it meets minimum standards for safety and potential efficacy. Once a promising compound is identified (and only a tiny percentage of candidates make it out of this development stage) it’s time to move onto the big leagues – submission for pre-clinical and clinical trials.


The Clinical Trial Process for Psychedelic Medicine

Once a drug has demonstrated promise in these initial evaluations, an Investigational New Drug (IND) application is submitted to the FDA. This application outlines the drug’s components, manufacturing processes, and proposed plan for human testing. It’s the green light that researchers need to transition to clinical trials on humans.

If the IND application is approved, the candidate compound can now move onto the human testing phases, known as clinical trials:

Phase 1

This round of clinical trials is focused primarily on safety. The candidate drug is given to healthy patients, usually with gradual dose increases, with the goal of tracking possible side effects and gauging proper dosing levels.

These trials generally have a smaller number of participants, between 20 to 100. With basic efficacy results already gathered in preclinical, the main point here is to evaluate the overall safety and predict the safest dosage.

Here the odds are much better with approx 70% of drugs moving to the next phase.

Phase 2

After safety and appropriate dosing have been established, the clinical trial can graduate to Phase 2. The proposed compound is tested on a larger group of people (from a few dozen to a few hundred) and the group will have the condition the drug is attempting to treat.

Here the move is from safety to both efficacy and safety. The trial is randomized, with some receiving the drug and others a placebo. This stage can run for up to 2 years and there’s a 30% of successful completion.

Phase 3

This is the big one. The final major step before drug approval. Here the candidate works with the FDA to design a trial that assesses the drug’s efficacy and monitors for adverse effects. Here the focus is if it works on a larger population size, with groups ranging from hundreds to thousands of patients.

Since this is the final crack at human trials, the group is made as diverse as possible across age, gender and race, with monitoring for correct dosage and long-term side effects.

The length of this phase can be 1 to 3 years and the success rate is 25-30%.


How Drugs Go from FDA Approval to Being Sold Commercially

After all these phases have been successfully completed, a New Drug Application (NDA) is filed with the FDA. This is the formal step where the drug manufacturer asks the FDA to consider approving a new drug for marketing.

Upon approval by the FDA, a drug becomes legal to prescribe and use within the parameters outlined by the FDA. But a drug’s journey doesn’t end there.

Now, it moves into what’s known as post-marketing surveillance or Phase 4 trials. This phase involves monitoring the drug’s use in public and collecting data about its effects in various populations and any side effects associated with long-term use.

In tandem, the manufacturing of the drug scales up, following strict quality control regulations set by the FDA. This process ensures that every pill, liquid, or injectable treatment is consistent in quality and efficacy.

The FDA approval and clinical trial process is a long yet essential journey that each drug must undertake to ensure it’s safe and effective for the wider public. In the rapidly expanding realm of psychedelic medicine, understanding these processes offers insightful perspectives for investors, patients, and enthusiasts.

The post A Deeper Look at FDA Approval and the Clinical Trial Process appeared first on Microdose.

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