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AcelRx Pharmaceuticals shares tumble after FDA rejects new drug application for Dsuvia

AcelRx Pharmaceuticals has requested a meeting with the FDA to discuss its recommendations for drug Dsuvia
Dsuvia is for the management of acute pain in trauma and ambulatory settings

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) shares slumped after saying the US Food and Drug Administration (FDA) did not approve its new drug application for pain treatment Dsuvia in its present form.

Shares plunged 59.81% to US$2.15 each in US pre-market trading.

The FDA said in a complete response letter (CRL) that the safety database was suitable in a number of patients but required additional data on at least 50 patients. The health regulator also recommended changes to the directions of use.

"We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA," said chief executive Vincent Angotti. 

AcelRx plans to hold talks with the FDA on the CRL with the aim of resubmitting its new drug application.

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AcelRx Pharmaceuticals Timeline

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