AcelRx takes another step in its recovery program, prepping a pain med pitch to the FDA
AcelRx clawed back another piece of its shattered market cap this morning after declaring a success with its last late-stage study of the powerful pain med sufentanil, delivered under the tongue. And the biotech $ACRX says it’s now ready to hustle back to the FDA for its marketing pitch, 18 months after it was handed a major setback on its lead pain program.
On high alert for problems presented by addictive opioids, AcelRx says the FDA wanted the biotech to recruit patients for a post-operative study that looked at how well patients did in managing their pain with this new sublingual approach to self-administration. And the company gave itself a clean bill of health, saying that a little more than a third of the patients suffered an adverse event — with most of the problems linked to nausea and headache.
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