Inspirion Delivery Technologies LLC
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Latest From Inspirion Delivery Technologies LLC
Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the
Latest citizen petition seeks to halt US FDA approval of Mallinckrodt's immediate release oxycodone abuse deterrent formulation; user fee action date is Nov. 16.
FDA finds no benefit in deterring intranasal abuse; final data not yet submitted to determine IV abuse deterrence.
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.