Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Intellipharmaceutics’ Oxycodone ER Returns To US FDA Panel Looking For Abuse-Deterrence Claim

Executive Summary

Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.

You may also be interested in...



One Loss, One Tie: US FDA Panels Prove Difficult For Opioid Sponsors Intellipharmaceutics, Esteve

Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.

Durect's Posimir: NDA Resubmission Raises Similar Safety Issues

How to score adverse events for Durect's surgical pain treatment could determine whether US FDA advisory committee recommends bupivacaine extended-release solution; agency questions whether Posimir's formulation may cause neurological adverse events.

Esteve’s Tramadol/Celecoxib: US FDA Cites No Major Concerns, But Also No Advantages

Agency’s briefing document for 15 January review of the fixed-dose product combining an opioid and nonsteroidal anti-inflammatory reflects application of opioid benefit/risk framework described in June draft guidance.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141487

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel