Subject: CCA
AcelRx announces receipt of Type A FDA meeting minutes and plans to resubmit the DSUVIA New Drug Application in Q2 2018
REDWOOD CITY, Calif., March 8, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced the receipt of the official January 2018 Type A meeting minutes from the U.S. Food and Drug Administration (FDA) relating to AcelRx's DSUVIAtm New Drug Application (NDA).
At this meeting, AcelRx proposed potential resolutions for the two main points identified in the Complete Response Letter (CRL) received from the FDA in October 2017. These main points were: (1) collect additional data in 50 patients with postoperative pain sufficient to evaluate the safety of DSUVIA at the maximum dosage in the proposed label, and (2) modify the Directions For Use (DFU) to mitigate the risk of misplaced tablets and validate the effectiveness of these changes in a human factors study. To address the first point, AcelRx proposed instead to reduce the maximum dose in the label to not exceed 12 tablets within a 24-hour period to more closely match the clinical utilization of DSUVIA in the trials. The Company proposed to the FDA that the existing data from the higher dosing patients in the DSUVIA and Zalviso clinical trials should be sufficient to evaluate the safety of DSUVIA at this reduced maximum available daily dose. The FDA stated that the proposed revision to the maximum daily dosage appeared reasonable and that it was expected that the high-exposure DSUVIA patient data combined with the high-exposure Zalviso patient data may be sufficient to support safety at maximal dosing in the DSUVIA NDA resubmission.
To address the second point in the CRL, AcelRx submitted to the FDA an updated DFU, and a revised protocol for the human factors (HF) study required to validate the effectiveness of the DFU changes. The FDA has reviewed and recently provided its comments to the updated DFU and HF study protocol, and the Company expects this study to be completed next month. In the NDA resubmission, AcelRx will provide these study results, along with the additional DSUVIA and Zalviso data analysis supporting the reduced maximum daily dosage. The Company intends to resubmit the NDA in the second quarter of 2018 after the completion of the HF study.
"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 in the second quarter of this year," said Vince Angotti, CEO of AcelRx. "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," continued Angotti.
Conference Call
As previously announced, AcelRx will conduct an investment-community conference call today, March 8, 2018 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its fourth quarter financial results at which time it will also discuss the outcome of the Type A FDA meeting. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to a webcast of the conference call live via the Internet may do so by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be archived on the AcelRx website for 90 days following the call.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has two product candidates including DSUVIAtm (sufentanil sublingual tablet, 30 mcg), known as DZUVEO outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, and Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings.
For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to the process and timing of an NDA resubmission for DSUVIA with the FDA, including the initiation and completion of the HF study as recommended in the FDA's CRL. These forward-looking statements are based on AcelRx's current expectations and involve significant risks and uncertainties. AcelRx's actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including, without limitation: risks related to the ability to complete and achieve successful results from the proposed HF study in connection with the resubmission of the DSUVIA NDA to the FDA; the possibility that the FDA may dispute or interpret differently the results of the Company's planned HF study to validate the effectiveness of the changes in the DFU, or the supplemental clinical information addressing the reduced maximum dosage to be included in the planned resubmission of the NDA for DSUVIA; any delays or inability to obtain and maintain regulatory approval of DSUVIA in the United States, DZUVEO in Europe and ZALVISO in the United States; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on November 9, 2017. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
SOURCE AcelRx Pharmaceuticals, Inc.
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