Regulatory Decision Summary for Alvimopan (*Entereg)

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:

Drug

Summary of Cancellation for alvimopan (*Entereg)

Medicinal ingredient(s):

alvimopan

Therapeutic area:

Peripherally acting µ-opioid receptor antagonist for management of post-operative ileus

Type of submission:

New Drug Submission (New Active Substance)

Control number:

189825
Overview

 

Decision issued

A Notice of Noncompliance was issued on January 10, 2017. The company cancelled its submission before a final decision was issued.

Date of cancellation

2017-03-29

What was the purpose of this submission?

The purpose of this New Drug Submission was to seek approval of alvimopan to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis.

What did the company submit to support its submission?

The sponsor submitted drug quality, pre-clinical and clinical components and a Risk Management Plan (RMP).

The efficacy of alvimopan was derived from six pivotal and supportive clinical efficacy multi-centre, randomized, double-blind, placebo-controlled, parallel group clinical trials in subjects receiving opioid analgesia for postoperative pain management following surgeries including partial bowel resection with primary anastomosis (that is [i.e.], partial small or large bowel resection [BR]; and radical cystectomy [RC]). Overall, a total of 2,154 patients underwent a surgery that included a bowel resection (n = 1,877 BR; n = 273 RC).

The safety of alvimopan in the management of post-operative ileus was assessed in ten randomized, placebo-controlled, clinical trials including 3,295 subjects (alvimopan [n = 1,793] or placebo [n = 1,502]) following surgeries that include partial bowel resection with primary anastomosis (i.e., partial small or large bowel resection and radical cystectomy; BR + RC) or extensive bowel manipulation (i.e., total abdominal hysterectomy; TAH).

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

A Notice of Noncompliance (NON) was issued. The reason for the NON was exclusively due to deficiencies in the Chemistry & Manufacturing component of the NDS. The sponsor chose to cancel their submission after receiving the NON.

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 for patients using SAP or in clinical trials.

Additional information

*Proposed Brand Name
Entereg