False · Brier 0.01
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 21 Jun 2024 · owen-1101
Quote
“It won’t get an FDA label, but it makes nightmares better.”
Closing line of a post on prazosin (Minipress), an old generic alpha-1 blocker approved for hypertension in 1988 and used off-label for PTSD nightmares. The author says it will never get an FDA label for PTSD because it is already generic and no sponsor will fund the trials.
Intake
- EventA proposition written from a template on the asset, with a resolution criterion and a named public source, before the outcome is looked up. The same event resolves every person's items on it. Method ›
- FDA approval of prazosin for PTSD or PTSD-associated nightmares
- AreaOne of five topic classes: regulatory decisions, clinical trial outcomes, company and market outcomes, payer and policy, practice adoption. Every event has one area. Method ›
- Regulatory decisions
- DeadlineThe date by which the event must happen for the item to be true. It comes only from the person's words through the anchor table. Method ›
- None stated · undated panelItems with no deadline in the person's words, scored on a uniform 24-month window from the statement date. Part of the headline panel since rules 1.1.0; also shown on its own. Method ›, 24-month window to 21 Jun 2026
- Probability
- 0.10 LexiconThe fixed five-bin table that turns a phrase into a probability. The strongest phrase in the claim sentence decides; coders never read tone. Method › · binOne of five lexicon steps: A 'will' 0.90, B 'probably' 0.70, C 'may' 0.50, D 'unlikely' 0.30, E 'never' 0.10. A stated number goes to the nearest bin for calibration only. Method › A · “It won't get an FDA label” · denialA statement that the event will not happen. Its probability on the event side is 1 minus the bin value. Method ›
- Base rateThe probability a published external study gives an event of that class and stage, fixed at intake. Halved when the item window is shorter than the class median time to decision. Never learned from the ledger's own items. Method ›
- None in the table
- Tags
- denial, retrospective
- Coder BCohen's kappa: agreement between two coders beyond chance, from -1 to 1. Reported for admit, event, deadline, bin and asserts from the second-coder match test. Method ›
- admittedA statement that passed intake: sincere, the person's own claim, forward-looking, inside the five areas, and not excluded by a reason code. Only admitted statements become items. Method › · event E-0026 · deadline none · bin A
Registry entry
The FDA approves prazosin for post-traumatic stress disorder or for PTSD-associated nightmares, a new labeled indication for any prazosin product.
TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) adds PTSD or PTSD-associated nightmares or sleep disturbance to the labeled indications of any prazosin product. A complete response letter, a positive advisory vote or a filing acceptance is not an approval. Off-label use, a clinical guideline, a compendium listing or a VA/DoD recommendation is not an FDA label. A label limited to PTSD-associated nightmares counts, since the claim's context concerns nightmares. FALSE when no such indication appears on a prazosin label in Drugs@FDA by the deadline.
Resolution source: Drugs@FDA; sponsor press release as a secondary source
Readings: 'an FDA label' = an FDA-approved indication on the prazosin label; PTSD or PTSD-associated nightmares both count.; 'It' = prazosin (Minipress), the subject of the post; any prazosin product (brand or generic) counts.
How to read
Coder A
Resolution
- State
- False
- Effective deadlineAn item enters the score only when its deadline has passed and the outcome is true or false. A claim already known true still waits for its deadline. Method ›
- 21 Jun 2026
- Outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method ›
- not occurred · checked through 13 Sep 2026
- Resolver note
- Drugs@FDA lists NDA 017442 (Minipress, Pfizer) with its most recent labeling supplements dated 2013-11-04 and 2015-02-27 and no efficacy supplement that adds an indication. The FDA label (s041) and the current generic label (Major Pharmaceuticals, Rev. 05/25, on DailyMed in September 2026) state one indication: treatment of hypertension. No PTSD, nightmare or sleep-disturbance indication appears on any prazosin label as of 2026-09-13; use for PTSD nightmares remains off-label, and guideline or compendium use does not count. The Drugs@FDA free-text search cannot be run by GET, so the NDA overview page and the DailyMed listing were checked instead.
- Evidence
- Drugs@FDA: MINIPRESS (prazosin hydrochloride) NDA 017442, approval history and supplements
- Minipress capsules (prazosin hydrochloride) for oral use: FDA-approved prescribing information, NDA 017442 s041
- PRAZOSIN HYDROCHLORIDE capsule [Major Pharmaceuticals], prescribing information Rev. 05/25 · 10 Sep 2026
- DailyMed SPL listing for prazosin hydrochloride (current labels, September 2026)
How to read
Registry
Timeline
1 claim against 59 events in the field.
Regulatory decisions