Bipolar Support Group

Lucky is the bp person that can take only one drug and live well and be happy. If Abilify, or Seroquel, or lithium can function as a stand-alone drug for this specific patient, wouldn't any of the other rainbow of bp drugs also successfully be considered as "stand-alone" if prescribed to a qualifying patient?

In other words, I wonder what the patient/bipolar diagnosis(es) criteria is that the FDA scores a given drug against. I guess there'd be other questions, too.

In more words, how political does this kind of thing get? Is it a question of how relative a drug is?

I say in advance, mia culpa — I meant no dissing to anyone. I be curious.

I could be very wrong of course.

For example, when Abilify first came out, it was approved by the FDA for the treatment of depression (and other things) WITH the addition of an addition of an antidepressant.

However, subsequent research has shown that Abilify ALONE is highly EFFECTIVE for the treatment of BIPOLAR disorder (and, apparently some other disorders - I'm not sure). Anyway, because of the research on bipolar, Abilify has been approved by the FDA as a "stand alone" treatment for bipolar. In other words, it can be used ALONE and is considered effective without the addition of an antidepressant or other medications for the treatment of bipolar - it is now a "stand alone" treatment.

Of course, we all know the effectiveness of bipolar treatments varies from individual to individual.

actually, I wasn't talking about any specific drug. I was mumbling about how does a drug achieve the status of stand-alone. What doors does a drug manufacturer need to open for the FDA to approve the drug for a specific status. it was a boring question.

Actually, it is a good question.

I could not find a definition for "stand alone" - but I did see that term used on the Abilify site.

However, on the FDA site, I did find a definition of "Combination Products": http://www.fda.gov/CombinationProducts/ AboutCombinationProducts/ucm118332.htm

On another site, I found it interesting that it takes an average of 12 yrs for a drug to go through the FDA approval process.

Hope this helps.