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Opioid Sponsors Enter 2019 At A Crossroads

 
• By Michael Cipriano

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 analgesics to market. 

Crossroad signpost saying this way, that way, the other way concept for lost, confusion or decisions - Image

Sponsors of opioid analgesics capped off a largely unsuccessful 2018 with the US FDA's rejection of SpecGx's immediate-release (IR) reformulation of Roxicodone (oxycodone hydrochloride) MNK-812, and these companies may now be at a crossroads for a while in terms of regulatory strategy.

The only opioid analgesic FDA gave its blessing to in 2018 was AcelRx Pharmaceuticals Inc

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