Trial Profile
A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 10 Aug 2023
Price :
$35
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At a glance
- Drugs Esreboxetine (Primary)
- Indications Fibromyalgia
- Focus Registrational; Therapeutic Use
- Sponsors Pfizer
- 07 Aug 2023 According to Axsome Therapeutics media release, company now expects to submit the NDA in the fourth quarter of 2023 or the first quarter of 2024.
- 01 Mar 2022 According to Axsome Therapeutics media release, company expects to submit the NDA for AXS-14 for the management of fibromyalgia in 2023.
- 15 Jun 2021 According to Axsome Therapeutics media release, based on results from this trial and CTP: 17545 the company announced its plan to submit a NDA for AXS-14 for the management of fibromyalgia following a pre-NDA meeting with the U.S. FDA. The NDA submission is currently anticipated in the fourth quarter of 2022 pending successful completion of manufacturing and other activities related to the product candidate. Acceptance of the NDA will be subject to the FDA's review of complete filing