Why AcelRx Pharmaceuticals Inc Got Cut in Half Today
AcelRx Pharmaceuticals (NASDAQ: ACRX) is down 57% at 12:41 p.m. EDT after the Food and Drug Administration rejected the company's pain medication Dsuvia. As I said earlier this month when the stock was running up in anticipation of an approval, nothing is certain when it comes to the FDA.
The FDA wants additional data on at least 50 patients to determine the safety of the drug when given at the maximum dose. At this point, AcelRx doesn't know if it can just send in data it already has on patients from its previous clinical trials, or if it'll need to run a new trial to collect the data the FDA wants.
The agency also wants changes to the Directions for Use instructions that come with the drug to address issues such as dropped tablets that have to be disposed of. The new instructions will have to be validated in a human factors study, but those tend to be straightforward and fairly quick.
Source: Fool.com
