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

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

Executive Summary

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.

You may also be interested in...



Delayed Onset Of Tramadol IV Creates Risk Of ‘Opioid Stacking,’ US FDA Finds

Avenue Therapeutics seems unlikely to get advisory committee support for its opioid analgesic over the agency’s conclusion that the drug’s ‘minimal benefit’ is outweighed by a potential risk from its delayed onset of pain relief. FDA has issued two complete response letters and denied Avenue’s first request for a formal dispute resolution.

Keeping Track: US FDA Clears Opioid Seglentis And Anti-Opioid Zimhi; CRLs For Revance, United; Delay For UCB

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Strides Fights COVID-19-Led Sales Slump With Endo Assets, Sputnik V

After a COVID-19-led manufacturing halt at its India facility and a slowdown in US launches hit Strides during the first quarter of FY22, the Indian firm is trying to fight back with an acquisition of assets from Endo and a growth strategy for Stelis Biopharma’s vaccines business, led by Sputnik V.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS141489

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