AcelRx Pharmaceuticals Inc. said it will resubmit its new drug application, or NDA, for Dsuvia in the second quarter of 2018.
The U.S. Food and Drug Administration rejected the drug, which is meant to treat moderate-to-severe acute pain, in October 2017, requesting additional data and changes to Dsuvia's directions for use, or DFU, label.
In a meeting, AcelRx presented potential resolutions for the FDA's two concerns. First, the company proposed to reduce the drug's stated maximum dosage, down to one more consistent with its clinical use in trials. The regulator said the proposal, which eliminates the need for AcelRx to gather additional data, appeared reasonable.
Second, the company submitted an updated DFU label meant to reduce the risk of misplaced tablets. AcelRx expects to resubmit the NDA upon the completion of a human factors study validating the efficacy of the DFU changes.
Completing the human factors study in April is the company's priority to meet the resubmission timeline, Vince Angotti, CEO of AcelRx, said in a news release.
Redwood City, Calif.-based AcelRx develops therapies for acute pain.
