Concerns that the extended-release oxycodone product poses the same potential for intravenous abuse as Endo’s withdrawn Opana ER drive FDA advisory committee recommendation against approval, laying the groundwork for a fourth complete response letter; FDA’s comparison of Remoxy to Opana during the meeting ‘borders on slanderous,’ PTI CEO Barbier tells Scrip, predicting sponsors will be dissuaded by the shifting regulatory goalposts for abuse-deterrent formulations.
Concerns about Remoxy's similarities to Endo's now-withdrawn Opana ER could mean the end of the long-acting opioid's development.
Pain Therapeutics Inc. is standing on the verge of a regulatory dead-end for Remoxy (oxycodone extended-release) following a US FDA advisory committee’s negative review June 26, and the company's CEO warns that the "changing goalposts" might deter future development in the abuse-deterrent opioid space.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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The end of semaglutide and tirzepatide shortages means large-scale compounding is declining, ICER noted. But compounded versions – and the demand for them – are likely here to stay.
