Was it pure luck or a case of players keeping their eye on the ball? Often, sports fans will spend hours happily dissecting an unexpected result in which the team came from behind and snatched victory from the jaws of defeat. This isn’t such a dramatic story, but it’s worth telling. The series of events that led to the creation of Viagra has some valuable lessons that can lead to understanding some of the more recent changes in the pharmaceutical world. We recently wrote a blog about a similar case in which the use of new drugs produced unforeseen and beneficial effects in a different area of medicine – the wonderful tale of Ozempic, Mounjaro, and weight loss.
To better understand the sequence of events that led to the creation of Viagra, it’s good to understand the “standard practice” that companies developing new medications have to go through before they can launch any new drug on the market.
The path from concept to market
The journey of a new medication from a laboratory concept to a product on the pharmacy’s shelves is a complex process that only sometimes reaches the intended destination. Barely one in ten ideas make it all the way through from concept to market. The process requires a blend of scientific innovation, rigorous testing, and regulatory scrutiny to ensure that any new drug is safe and effective for public use.Step 1 – Research and discovery
Scientists start to work on understanding diseases at a molecular level. This involves identifying potential targets for treatment – like a specific protein involved in a disease process. Nowadays, artificial intelligence (AI) plays a significant role in the opening phase. AI can analyze vast amounts of data to predict which compounds might effectively interact with a specified target, significantly speeding up the discovery process.Step 2. Synthesis and laboratory testing
Once a promising compound is identified, it is synthesized and subjected to preclinical testing. This involves a series of experiments, often conducted in test tubes (in vitro) and on animal models (in vivo), to evaluate the drug’s safety and effectiveness. Scientists study how the compound behaves in the body, its toxicity levels, and its potential side effects. The goal here is to gather enough preliminary evidence to justify human trials.Step 3. Clinical trials
Clinical trials are conducted in several phases:- Phase I tests the drug on a small group of volunteers who enjoy good health to assess its safety, tolerability, and pharmacokinetics – how the drug is absorbed, distributed, metabolized, and excreted in the body. Whether it actually does the job intended is of secondary concern.
- Phase II shifts the focus to efficacy. Trials involve patients with the condition the drug is meant to treat. These trials also help determine the optimal dosing and further assess safety.
- Phase III is on a larger patient group, including double-blind tests of the drug against a placebo. This phase has to confirm the drug’s effectiveness, monitor side effects, compare it to other commonly used treatments for the same condition, and collect information that will allow the drug to be used safely.