Officials with AcelRx Pharmaceuticals, Inc. announced in a press release this week that the FDA is requesting an additional clinical trial relating to their new drug application for Zalviso.
In the release, AcelRx officials noted that late last week they received correspondence from the FDA stating that in addition to the bench testing and two human factors studies it has performed, an additional clinical study is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures.
In the statement, AcelRx officials noted they plan to meet with the FDA "to discuss and clarify the agency's belief that an additional clinical study is needed, and the potential design and objectives of such a study."
Company officials noted that as a result of this communication "and the need for clarity with FDA, AcelRx will not be making the Zalviso NDA resubmission this quarter."
Zalviso would allow hospital patients with moderate-to-severe acute pain to self-dose with sublingual sufentanil tablets to manage their pain.
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, provided an update on the timing and potential content of the resubmission of the New Drug Application or NDA for Zalviso.