MDMA and FDA approval process

People are excited about the state of MDMA (also called ecstasy). And there are good reasons.As last month in New York Times:

…People who receive MDMA during treatment [in clinical trials] Compared with patients receiving treatment and ineffective placebo, the severity of their symptoms was significantly reduced. After two months of treatment, 67% of participants in the MDMA group no longer met the diagnostic criteria for PTSD, compared to 32% in the placebo group.

This is a very important clinical evidence of the efficacy of MDMA.

Once relegated to the party scene, sponsors, scientists and doctors are now testing the effectiveness of MDMA in treating certain diseases. As we all know, ecstasy is currently undergoing clinical trials based on an investigational new drug (“IND”) application submitted to the U.S. Food and Drug Administration (“FDA”). The sponsor of the clinical trial is testing the efficacy of MDMA in the treatment of post-traumatic stress disorder. MDMA is in the third phase of clinical trials, and approval as a new drug is no longer just a hypothesis. Once MDMA is proven to be effective and safe for patients with PTSD, the FDA should approve MDMA.

The FDA’s pre-market approval process is dynamic, demanding, and costly. Few IND applications are finally approved by the FDA. To understand the requirements for IND sponsors, it is useful to review the preclinical and clinical processes.

Before starting clinical trials, IND sponsors usually conduct preclinical trials on animals to observe the toxicity of the drug.Such a test can be in vivo or in vitroThese studies are usually small and test dosing regimens and toxicity levels. If these preclinical trials show promise, then sponsors will turn to human clinical trials.

According to the U.S. Food and Drug Administration (click here For more information about FDA), the clinical trial process usually includes the following four stages:

Phase 1-This phase usually lasts a few months and focuses on safety and dosage issues. The typical study size is 20 to 100 participants who meet specific criteria set by the sponsor. Approximately 70% of drugs are transferred from stage 1 to stage 2.

As the Phase 1 trial continues, sponsors and researchers will answer research related to early information about how the drug works in the body, side effects associated with increased doses, and how the effectiveness of the drug determines how best to administer the drug to limit the drug problem. Risk and maximize the possible benefits. This is important for the design of the Phase 2 study.

Phase 2-Phase 2 research can last from a few months to several years. At this stage, the sponsor explores the efficacy and side effects of the drug. The study sample for the second phase of the trial is larger, usually involving several hundred participants. Approximately 33% of drugs are transferred from phase 2 to phase 3. Therefore, this phase of clinical trials is more demanding than Phase 1.

Phase 3-The Phase 3 study is a larger clinical trial involving 300 to 3,000 subjects. This stage is the final stage of the FDA’s pre-approval process. The Phase 3 study continues to test efficacy and monitor adverse reactions. Approximately 25% to 33% of drugs are approved in Phase 3. Therefore, at this time, only 6% to 8% of Phase 1 drugs were approved by the FDA.

The Phase 3 study provided most of the safety data. In the first few stages of clinical trials, less common side effects may go undetected. Because the Phase 3 study is larger and longer in duration, the results are more likely to show long-term or rare side effects.

Phase 4 occurs after the drug is approved by the FDA. This phase monitors the safety and effectiveness of thousands of patients.

The above is a simple summary of the FDA clinical trial process-the actual process is extremely detailed and demanding. But not all new drugs follow the above outline. For example, the scale of clinical trials of some new drugs is much smaller, even in phase 3. As long as the results of the study are statistically significant (that is, the results can be extrapolated to the entire population), the sample size is less important.

In order for MDMA to reach stage 3, important clinical evidence on safety, dosage, and effectiveness has been collected. This is no small matter. Any clinical trial requires a lot of expenditure. According to the Johns Hopkins Bloomberg School of Public Health, “[c]The median cost of clinical trials to support FDA approval of new drugs is US$19 million…” However, a sufficient budget is only one of the many variables required to successfully complete a clinical trial. In the final analysis, effectiveness and safety are the two most difficult to control. variable.

Will MDMA be approved by the FDA? Time will prove everything, but the initial evidence is very promising. At the same time, please check the following for related blog posts about MDMA:

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