Regulatory Decision Summary for Oxycodone (*XTAMPZA ER)
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Summary of Cancellation: oxycodone (*XTAMPZA ER)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
July 27, 2018
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain approval of XTAMPZA ER, a controlled-release formulation of oxycodone in waxy excipients intended to be tamper-resistant, for the management of pain.
What did the company submit to supports its submission?
The sponsor submitted drug quality, pre-clinical and clinical components.
The pivotal clinical safety and efficacy information consisted of a Phase 3 pivotal study (CP-OXYDET-08). The study was conducted in opioid-experienced and opioid-naïve patients with moderate-to-severe chronic low back pain with a randomized withdrawal design.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
The review of the submission was nearing completion and Health Canada and the sponsor were finalising the Product Monograph and labels and discussing minor quality issues.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact on SAP and/or clinical trials.
Additional information
*Proposed Brand Name:
XTAMPZA ER