AcelRx rally quickly fizzles after FDA offers a guarded warning about its latest pain drug pitch
A little less than a year after the FDA kicked back AcelRx’s sublingual jolt of the pain med sufentanil, Dsuvia (ARX-04), in search of more safety data, in-house reviewers at the FDA are ready to hand it over to an outside panel to get their opinion on its potential.
In a cover memo, the FDA’s Sharon Hertz said last year’s CRL was prompted by two key concerns: “the safety of sufentanil sublingual tablets 30 mcg in patients requiring the maximum dosing proposed for labeling and the risk of misplaced tablets.”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.