Postmarketing Commitments and Requirements

Postmarketing commitments (PMCs) and requirements (PMRs) refer to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. Some of the studies and clinical trials may be required by FDA; others may be studies or clinical trials a sponsor has committed to conduct.  

Additional information about these studies can be found on the FDA website

Endo is committed to patient safety and to supporting transparency about PMC and PMR obligations. Below is a list of Endo’s ongoing and completed PMCs and PMRs. Additional information about these studies can be found on the FDA website.  Click Here and search “Endo” in the “Applicant" field to learn more about our  requirements/commitments.


Study ID

Study Description

Intervention

Study Phase/Type

Recruitment Status* / Clinical Study Results
AUX-CC-810 Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated with AA4500 for Peyronies Disease XIAFLEX®/XIAPEX® (collagenase clostridium histolyticum) Phase 4 Postmarketing Requirement Active, not recruiting
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NCT02298829
EN3202-036 Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets Pediatric Research Equity Act Commitment PDF icon
EN3202-037 A Multicenter Study of the Safety, Tolerability, Effectiveness and Pharmacokinetics of Oxymorphone HCl Extended-Release Tablets in Pediatric Subjects Requiring an Around-the-Clock Opioid for an Extended Period of Time OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets Pediatric Research Equity Act Commitment Recruiting
EN3203-010 Open-Label Safety, Pharmacokinetics, and Effectiveness Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects. OPANA® (oxymorphone hydrochloride) Tablets Pediatric Research Equity Act Commitment PDFicon.png
EN3319-302 Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate-Release Oral Liquid in Post Surgical Pediatric Subjects Oxymorphone hydrochloride immediate-release oral liquid Pediatric Research Equity Act Commitment Recruiting
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NCT01210352
EN3319-304 An Open-label Single-dose and Randomized, Double-blind, Placebo-controlled Multiple-dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oxymorphone HCl for Acute Moderate to Severe Postoperative Pain in Pediatric Subjects Oxymorphone hydrochloride immediate-release oral liquid Pediatric Research Equity Act Commitment Recruiting
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NCT02687451
EN3350-302 Time to Eugonadal Range, Time to Steady State and Drying Time FORTESTA® (testosterone) Gel   newWindow_gray.png
NCT01228071

 


*Recruitment Status


Definition

Not yet recruiting

participants are not yet being recruited
Recruiting

participants are currently being recruited
Enrolling by invitation

participants are being (or will be) selected from a predetermined population
Active, not recruiting study is ongoing (i.e., patients are being treated or examined), but participants are not currently being recruited or enrolled
Completed the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)
Suspended

recruiting or enrolling participants has halted prematurely but potentially will resume
Terminated recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
Withdrawn study halted prematurely, prior to enrollment of first participant

 


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Endo International plc is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA.

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