Remoxy's "Complete Response" Letter Has No Clear Culprit But Many Suspects
This article was originally published in The Pink Sheet Daily
Pfizer's abuse-deterrent, extended-release form of pain drug oxycodone faces legal, regulatory and manufacturing challenges.
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Novartis completes the divestiture of its vaccines business by selling off two influenza vaccines to Australia’s CSL Ltd. Zogenix buys out Britain’s Brabant pharma and Pain Therapeutics is searching for a new partner for Remoxy after Pfizer drops the abuse-deterrent opioid.
Pfizer terminates agreement with Pain Therapeutics after reviewing top-line results of five studies done to address FDA complete response letter; Pain says data supports refiling of NDA for its abuse-deterrent long-acting oxycodone formulation by mid-2015.
Abuse-deterrent opioids address a serious unmet need and help differentiate brands from the field of generics, but so far Purdue’s OxyContin remains the only opioid on the market with abuse-deterrent claims, even though FDA recently approved two new opioid analgesics.