Medication approval journey
gabapentin (Neurontin)
Approved for Postherpetic neuralgia, and adjunctive therapy for partial-onset seizures
Before changing anything
Stopping abruptly can be dangerous — never do it without medical supervision
Do not stop abruptly. Abrupt discontinuation of gabapentin or pregabalin can trigger seizures, including in people who have never had one. Any change should be a 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?
NEURONTIN was evaluated for the management of postherpetic neuralgia (PHN) in two randomized, double-blind, placebo-controlled, multicenter studies. The intent-to-treat (ITT) population consisted of a total of 563 patients with pain for more than 3 months after healing of the herpes zoster skin rash (Table 6).
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- December 30, 1993
- Application
- NDA020235
- Review
- PRIORITY
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 gabapentin (Neurontin) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
