The FDA forced AcelRx Pharmaceuticals to go back to the drawing board to refashion a better safety plan for its new pain therapy Dsuvia (ARX-04). And that paid off Friday with a big endorsement from the outside experts the agency drew together to review their marketing application.
The group voted a lopsided 10-3 in favor of a green light, as these experts were able to look past regulatory concerns about the potential for abuse and accidental exposure posed by the 30 mcg sufentanil tablets.
That helped drive a big rally for their shares $ACRX, which are up 29% in pre-market trading Monday.
To get an approval through a vigilant FDA, the biotech has repeatedly emphasized that the under-the-tongue med will not be available in the community, but only used in the hospital by trained personnel. But several of the experts reportedly shared the FDA’s concerns that the small pills could wind up on the floor, within reach of children.
“The FDA suggested we modify the directions for use to better clarify the sublingual space, and they also wanted more confirmation that the health care provider was the one administering the drug,” AcelRx CEO Vince Angotti told Healio. “We went back and attached instructions to each and every Dsuvia packet and had health care providers administer the drug to mock patients and achieved close to 100% accuracy.”
We’ll soon see if the company can pass the final review by the FDA.
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