Five long years after the FDA rejected Remoxy for the second time, Pain Therapeutics has now been handed its third painful FDA slap down for the supposedly abuse-deterrent opioid. This time the biotech says that it can expect to take about a year for the fourth assault — after it has a chance to review its options and chat with regulators.
“The CRL focuses on the abuse-deterrent properties of Remoxy ER and proposed drug labeling,” Pain said in a statement this morning. There was no mention of another study requirement.
Investors, though, weren’t quick to see any upside left. Pain’s stock $PTIE ended the day down 51% today.
Pain Therapeutics and its remaining investors have had to contend with a slow but steady drumbeat of bad news on the Remoxy front. Once allied with pharma giant Pfizer, the biotech was left to its own devices back in 2014.
The opioid epidemic in the US has triggered a variety of new development programs aimed at creating new and powerful meds that can’t be abused. Pain’s approach involved making the opioid taste bad to stop people from using it to get high. But regulators have been leery of this product for years.
Get Endpoints News in your inbox
News reports for those who discover, develop, and market drugs. Join 13,500+ biopharma pros who read Endpoints News articles by email every day. Free subscription.
Subscribe to Endpoints
John Carroll, Editor and Co-Founder
We produce two daily newsletters designed to give you a complete picture of what's important in biopharma.