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The FDA approves a medication like tapentadol only after an extensive research and development (R&D) process that can take 10 to 15 years. This process makes sure the drug is both safe and effective. The process starts with the discovery phase, where scientists look at diseases and try to find potential targets for treatment, for example, certain proteins or cellular pathways.

Instead, they screen many compounds to find out which might have the desired effect on the target. After they have found a promising candidate like tapentadol, they test it in the laboratory and in animals to learn how it works in the body and how safe and effective it is. This is called preclinical research. If the compound looks promising, the company files an Investigational New Drug (IND) application with the FDA.

All the preclinical data and the proposed plan for testing in humans are contained in this application. Tapentadol went through three phases of clinical trials with FDA approval. Phase 1 is a small group of healthy volunteers to see if it is safe and what the dosage should be. Phase 2 involves a larger group of patients with the target disease to evaluate effectiveness and assess safety further.​

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