trending Market Intelligence /marketintelligence/en/news-insights/trending/SgfPZkVyAqKVkP6RTw4AXw2 content esgSubNav
In This List

US FDA rejects AcelRx Pharmaceuticals' pain drug

Video

According to Market Intelligence, December 2022

Blog

Insight Weekly: Layoffs swell; energy efficiency PE deals defy downturn; 2023 global risk themes

Blog

Insight Weekly: Energy crisis cripples Europe; i-bank incomes rise; US holiday sales outlook

Blog

Japan M&A By the Numbers: Q3 2022


US FDA rejects AcelRx Pharmaceuticals' pain drug

AcelRx Pharmaceuticals Inc. said the U.S. Food and Drug Administration rejected its new drug application for DSUVIA to treat moderate-to-severe acute pain.

AcelRx submitted the application in December 2016. In a complete response letter, the U.S. FDA requested additional data on at least 50 patients and certain labeling changes in usage directions.

The 2016 application was supported by results from the entire ARX-04 clinical program, including data from four trials that showed improvement in pain intensity within 15 to 30 minutes of dosage.

"We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA," AcelRX CEO Vincent Angotti said in a statement.