I'm just a pill. Yes, I'm just a pill. And I'm sitting here ...
Oh, hi. My name is Nupil. I'm a new drug, or at least I hope to be. Right now, the FDA is deciding whether to approve me. See that big office building? That's the Center for Drug Evaluation and Research. It's as important as it sounds. The fate of all new medicines that want to be sold in the U.S. is decided here.
Inside, FDA reviewers are carefully examining all the information that's known about me and talking it over together. They sure are busy. There are more than 100,000 pages of data, and it will take a team of reviewers several months to review. I guess I'll just have to sit here and be patient.
How did I end up here? Why, I'm glad you asked. That's an interesting story.
A Molecule Stands Out
About 12 years ago, I started out as a molecule, one of thousands researchers created in a laboratory. The scientists screened us, one by one, looking for some special properties. I was added to some cells in a test tube to see what I would do.
It was a long time ago, but I remember I liked almost everything about those cells, except for one awful little enzyme -- an enzyme that could make people sick. That enzyme really annoyed me, so I blocked its production, but left everything else alone. Well, the scientists were plenty pleased. I only did what came naturally to me, but now I know it was exactly what they were hoping for.
I didn't have a name yet, just a number: ABCD-523.
The Testing Begins
The scientists then started testing me in laboratory rats. The purpose of this was to see if I did the same thing in live animals that I did in the test tube. They also wanted to know if I had any toxic effects. They measured how I was absorbed and passed though the animal's body.
As Alan Goldhammer, PhD, associate vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA), told me, "It's easy to identify lots of things that work inside a test tube." The challenge is finding something that works in a living body.