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Postmarketing Commitments & 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 and 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, which are listed on clinicaltrials.gov, along with active links to learn more about them.

Medical Therapeutics

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 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 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 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 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 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 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 NCT02687451
EN3350-302	Time to Eugonadal Range, Time to Steady State and Drying Time	FORTESTA® (testosterone) Gel		Completed NCT01228071

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Postmarketing Commitments & Requirements

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