Benzinga | Jun 17, 2021 08:34AM EDT

AcelRx Reports Deal With FDA To Address Warning Letter Received For DSUVIA Promotional Materials

AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced it has reached agreement with the Food and Drug Administration (FDA) with regards to finalizing corrective actions AcelRx has taken or plans to take in response to the previously announced FDA warning letter, dated February 11, 2021, regarding certain DSUVIA promotional materials.

The FDA has agreed with AcelRx's proposed plan to update certain promotional materials, including providing a letter to healthcare professionals (DHCP letter) explaining the corrections to the discontinued promotional materials. AcelRx will also include this DHCP letter on the DSUVIA.com website for a period of eight months. All promotional materials currently in use by AcelRx's commercial team have been updated to address the FDA's concerns. AcelRx 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.