AcelRx in Agreement with FDA On Dsuvia Promotional Materials Warning Letter
June 17 2021 - 9:33AM
Dow Jones News
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 michael.dabaie@wsj.com
(END) Dow Jones Newswires
June 17, 2021 09:25 ET (13:25 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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