AcelRx Pharmaceutical's New Drug Application for DSUVIA was rebuffed, pending more safety and use data.
An investigational pain medication up for US Food and Drug Administration (FDA) approval has been pushed back, pending supplemental data.
The 30-mcg sufentanil sublingual tablet (DSUVIA) by AcelRx Pharmaceuticals received a Complete Response Letter (CRL) from the FDA. The letter states the product’s New Drug Application (NDA) cannot be approved in its current form.
DSUVIA — marketed as ARX-04 outside of the US — is an opioid analgesic that, with its sufentanil pharmacokinetic profile, is designed to reduce moderate-to-severe acute pain and alleviate IV administration dosing errors. It is administered via a non-invasive single-dose applicator (SDA) in medically supervised settings, avoiding the short-duration pitfalls of intravenous administration.
The CRL received by AcelRx primarily recommends that supplemental data on at least 50 patients dosed at the maximum rate of proposed labeling shows its safety, and that certain changes to its Directions for Use address use-related errors to be validated through another study.
AcelRx will request a meeting with FDA regarding the CRL, and will move forward with plans to resubmit the DSUVIA NDA. Vincent J. Angotti, AcelRx chief executive officer, called the CRL recommendations “manageable,” and expressed intentions to cooperate.
“We remain focused on the NDA resubmission and our mission to provide physicians and patients with precise and efficient non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings,” Angotti said.
As ARX-04, the potential treatment is also currently undergoing European Medicines Agency consideration. Its European Marketing Authorization Application (MAA) is under scientific review.