Medication approval journey
duloxetine (Cymbalta)
Approved for Major depressive disorder in adults
Before changing anything
Stopping abruptly causes withdrawal effects that can be severe
SNRIs — venlafaxine especially — are associated with some of the most difficult withdrawal of any antidepressant, partly because of their short half-life. Do not skip doses or stop abruptly. Any change should be a slow, prescriber-supervised taper.
How long the trials actually ran
The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.
The approval, step by step
Step 1
What the approval was actually based on
Which studies did the FDA rely on, how long did they run, and who was in them?
The efficacy of CYMBALTA as a treatment for MDD in adults was established in 4 randomized, double-blind, placebo-controlled, fixed-dose trials in adult outpatients (18 to 83 years) meeting DSM-IV criteria for MDD: In Studies MDD-1 and MDD-2, patients were randomized to CYMBALTA 60 mg once daily (N=123 and N=128, respectively) or placebo (N=122 and N=139, respectively) for 9 weeks In Study MDD-3, patients were randomized to CYMBALTA 20 or 40 mg twice daily (N=86 and N=91, respectively) or placebo (N=89) for 8 weeks
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- August 3, 2004
- Application
- NDA021427
- Review
- STANDARD
Step 3
What was added after it was on the market
Which warnings arrived only after millions of people were already taking it?
Step 4
What independent research has found since
What has been learned by people who were not selling it?
Step 5
What still is not known
Which questions you might reasonably have has nobody answered yet?
Open duloxetine (Cymbalta) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
