Pain Therapeutics Confident It Has US Approval Pathway Set For Remoxy ER
Biotech says it can complete two FDA-mandated studies by year-end and re-file the NDA rejected three times previously by the US agency. Pain Therapeutics also says it will not attempt to commercialize the abuse-deterrent opioid product without a partner.
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Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.
Agency reviewers see lower potential for intranasal abuse with Pain Therapeutics' extended-release opioid compared to immediate-release oxycodone, but an increased abuse potential when Remoxy is chewed compared to swallowing the drug intact.
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