“So my antidepressant isn’t all it was cracked-up to be. Well, there’s gotta’ be something exciting coming soon. Right? Please, tell me I’m right!”
With the introduction of fluoxetine (Prozac) in 1987, we were led to believe a new frontier of antidepressants would bring the cure-all for our depression and anxiety woes.
Well, not exactly. So will the meds of yet another new frontier usher in ultimate relief? Hmmm.
Research and Development
As of July 2010, pharmaceutical and biotechnology companies in the United States were developing 71 medicines for the mood disorders and 38 for the anxiety disorders. The numbers look great, but you have to keep a few things in mind…
- Included are drugs already being used off-label. That simply means a physician may prescribe a med for, say, panic disorder. But the FDA hasn’t approved it for that application. So the drug company submits an application for a new approval.
- Many of the drugs are crossovers. They’re intended to treat depression and anxiety, and they’re counted in both categories.
- Many of the drugs will never see a pharmacy shelf.
The research and development of new medicines is dicey biz. It’s costs a company an average of $1.3 billion to bring a drug to market. And that can take 10-15 years – if it happens at all.
FDA Drug Approval Process
So what makes the research and development of a medicine so expensive – and such a lengthy crap-shoot? Soak-in the FDA approval process…
- Preclinical Testing: All about assessing the safety of a med before human testing.
- Investigational New Drug (IND) Application: Includes details such as preclinical testing results, mode of action, side effects, manufacturing details, and a clinical trial plan.
- Clinical Trials: Only five of 250 drugs that enter preclinical testing make it this far. Here’s what’s involved…
- Phase I: Testing in small groups (20-100) of healthy volunteers. The goal is to determine safety, dosage range, and how the medicine works through the body.
- Phase II: Placebo-controlled trials involving 100-500 volunteer subjects who actually have the disease.
- Phase III: The placebo-controlled trials include 1000-5000 subjects in hospitals, clinics, and docs’ offices.
- New Drug Application (NDA): Filed with the FDA if all of the data looks good to the manufacturer. An NDA is typically 100,000+ pages.
- Phase IV: May be required before approval. The cost can be as much as $30 million.
- FDA Review/Approval: The FDA brain-trust has its turn at the data. They may even convene an advisory committee to swirl things around. If the stars line-up, the FDA approves the drug and it hits the market.
An amazingly complicated, long, and expensive process, don’t you think? FYI – the FDA has a Fast Track Development Program for medicines that treat serious diseases and fill an unmet medical need.
You know, there’s an issue here that really bugs me. I’ll use the newly approved antidepressant vilazodone (Viibryd) for example purposes. Let’s say it took 12 years from the onset of research and development to put Viibryd on pharmacy shelves. That would mean Viibryd was conceived and developed using 1999 technology.
Isn’t it incredibly frustrating that current meds can’t be grounded in current technology?
What Meds Look Good?
Well, I’m sorry to say that only two medicines on the light-end of the development tunnel appear to be worth a goose-bump…
- LuAA21004 (Lundbeck): In Phase III development for the treatment of depression and anxiety. It promotes the production of serotonin.
- EB-1010 (Euthymics Bioscience): In Phase II/III development for the treatment of major depressive disorder. It’s a triple reuptake inhibitor; impacting serotonin, norepinephrine, and dopamine. We discussed it in yesterday’s article. Click here.
I wish I had better news to report. The fact of the matter is we simply don’t know enough about the workings of neurons and the brain to design truly revolutionary medicines for the mood and anxiety disorders.
Wouldn’t it be nice if Big Pharma would acknowledge that, instead of cranking-out new meds based upon old technology?
You know what? We’re going to have to make-do with what we have. Meds wise – given what we’re learning about antidepressants – perhaps even less.
Make it your business to learn, apply, and practice all you can about emotional, mental, spiritual, and physical self-management. If you have a therapist, work extra hard. If you don’t have a therapist, do all you can to get hooked-up.
Finally, stick with chipur. We’ll get through it together…