Back in October 2017, AcelRx Pharmaceuticals received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Dsuvia (sufenetanil sublingual tablet) for pain. Today, the company released the minutes from its Type A meeting with the FDA and its plans to resubmit the NDA in the second quarter of this year.
Dsuvia is designed to cut moderate-to-severe pain as well as dosing errors by using a non-invasive single-dose applicator in medically supervised settings. Sufentanil is an opioid that is marketed currently for intravenous and epidural anesthesia and pain treatment. The FDA’s rejection was based on the need for another 50 patients to be evaluated to assess the safety of Dsuvia at the maximum dose, and to ensure proper administration of the tablet with the single-dose applicator.
AcelRx’s response to the first issue was to instead reduce the maximum dose in the label to not exceed 12 tablets within a 24-hour period. The company suggested that the existing data from the higher dosing patients in the Dsuvia and Zalviso trials should be good enough to evaluate Dsusvia’s safety at the lower maximum available daily dose. The FDA agreed to that point.
Zalviso is another drug/device combination product designed to deliver 15 mcg of sufentanil. It is approved in Europe, but not yet in the U.S.
For the second point, AcelRx submitted an updated Directions for Use (DFU) and revised the protocol for the Human Factors study. The FDA has reviewed and commented on it and the company expects the study will be wrapped up in April. The NDA resubmission will include these results as well as additional data.
"We are pleased with the constructive nature of the meeting with the FDA, which has provided a clear path to resubmit the Dsuvia NDA, which we expect to accomplish n the second quarter of this year," said Vince Angotti, AcelRx’s chief executive officer, in a statement. "Completing the HF study next month is now the priority to meet our resubmission timeline. We continue to believe Dsuvia can satisfy a large unmet need within healthcare settings, and we remain focused on our mission to provide healthcare providers and patients with non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings."
The company also released its fourth-quarter financials today. As of December 31, 2017, the company had $60.5 million in cash and short-term investments. Its revenue for the full year were $8 million, made up of $7.1 million from a collaboration deal with Gunenthal and $0.9 million from work on Dsuvia performed under a U.S. Department of Defense contract.
Research-and-development expenses and G&A expenses for the year were $36 million. Net loss for the full year of 2017 was $51.5 million. For 2018, the company expects to resubmit the NDA for Dsuvia in the second quarter, is expecting an opinion on Dzuvia in Europe from the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use in the first half of the year, and expects an FDA advisory committee meeting for Dsuvia in the third quarter of this year. The anticipated PDUFA date for Dsuvia in this year’s fourth quarter. The company also expects to resubmit the NDA for Zalviso in the second half of this year.
Angotti said in a statement, "We also continued to demonstrate financial discipline through control of our spending, and ended the year with over $60 million in cash and investments, which provides sufficient liquidity heading into an expected PDUFA date later in the year."
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