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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 Completed
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NCT02298829
EN3000-101 An Open-Label, Randomized, Parallel-Group, Three Treatment Arm, Multicenter Study on Hypogonadal Males to Evaluate the Effect on 24-Hour Ambulatory Blood Pressure After 16-Week Continuous Treatment with Marketed Testosterone Products AVEED®
TESTIM®
FORTESTA®		 Phase 4 Recruiting
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NCT04456296
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 Terminated
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NCT00765856
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 Suspended
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NCT04681027
EN3203-010 Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects OPANA® (oxymorphone hydrochloride) Tablets Pediatric Research Equity Act Commitment Completed
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NCT00801398
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 Completed
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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 Terminated
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NCT02687451
EN3350-302 Time to Eugonadal Range, Time to Steady State and Drying Time FORTESTA® (testosterone) Gel   Completed
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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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