AcelRx in Agreement with FDA On Dsuvia Promotional Materials Warning Letter

By Michael Dabaie

AcelRx Pharmaceuticals Inc. said it reached an agreement with the Food and Drug Administration on finalizing corrective actions in response to an FDA warning letter regarding some Dsuvia promotional materials.

Dsuvia is indicated for use in adults in healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.

The FDA said in February it issued a warning letter to AcelRx for what it called false and misleading promotion of Dsuvia. "Critical conditions for the safe use of Dsuvia are not appropriately conveyed in the promotional communications cited in the warning letter," the FDA said in February.

The company said the FDA agreed with AcelRx's proposed plan to update some promotional materials, including providing a letter to healthcare professionals explaining the corrections to the discontinued promotional materials. AcelRx will include the letter on the DSUVIA.com website.

The company said that all promotional materials currently in use by AcelRx's commercial team have been updated to address the FDA's concerns.

AcelRx said it expects to receive a close-out letter from the FDA after the DHCP letters have been sent to the identified healthcare professionals and the letter has been posted on the website for eight months.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

June 17, 2021 09:25 ET (13:25 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.