report predicts trf opioid er boom

The FDA’s promotion of tamper resistant formulation (TRF) therapies could well result in the departure of non-TRF treatments from the market, according to analysts from Frost and Sullivan, in a newly released report Competitive Analysis of the Global Opioid Therapeutics Market. The report predicts that orally-delivered pain products will continue to dominate the market, with Oxycontin currently leading this category, generating $2.77 billion in sales in 2012. The transdermal category is led by Johnson & Johnson’s Duragesic (fentanyl) patch for cancer-induced pain and Endo’s Lidoderm (lidocaine) patch for chronic pain.

Frost and Sullivan predicts that the FDA’s push for abuse-deterrent formulations will spell a boom for extended-release opioids. Immediate-release products currently dominate the market, with a 91% market share. However, with the FDA favouring TRF therapies, Frost and Sullivan believe that extended-release products will find greater favour among drug developers and make inroads into the immediate-release market. The analysts believe that this will create a huge opportunity for new TRF opioid products to remain branded.(1,2)

Meanwhile, the FDA has accepted for review a New Drug Application (NDA) by Purdue for Targiniq ER (oxycodone /naloxone) twice-daily tablets for the management of chronic pain. Rather than using a physical or chemical barrier to deter abuse, Targiniq adds an opioid antagonist (naloxone) which is designed to interfere with, reduce, or defeat the euphoria associated with abuse.

Purdue's NDA is based on the results of a 12 week, double blind, randomized placebo controlled U.S. clinical trial with 600 opioid experienced patients, as well as supporting data from other clinical studies. The submission also includes data from clinical abuse liability studies designed and conducted consistent with the FDA’s January 2013 Draft Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling. In the NDA submission, Purdue Pharma is requesting the inclusion of language about abuse deterrence in the product’s proposed label based on the results of these studies.

This product was first approved in Germany in 2006 and is currently marketed in 32 countries, including Australia. If Targiniq is approved by the FDA, there will be three TRF oral oxycodone ER products available in the US - OxyContin ER with INTAC crush resistant technology, Targiniq with naloxone deterrent and Impax generic OxyContin ER with INTAC technology. (3,4)


(1) http://www.pharmatimes.com/Article/13-12-18/FDA_pain_market_moves_creating_huge_opportunities.aspx

(2) http://blog.pharmexec.com/2013/12/18/fda-push-for-trf-therapies-will-disrupt-pain-market/

(3) http://www.painmedicinenews.com/ViewArticle.aspx?d=Web+Exclusives&d_id=244&i=December+2013&i_id=1023&a_id=24572

(4)http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf