AcelRx Pharmaceuticals Announces Anticipated 2016 Milestones

- ARX-04 ER and Postoperative Study Results, NDA Submission

- Initiation and Completion of Final Phase 3 trial in the U.S. for Zalviso, NDA Resubmission

- Zalviso™ Commercial Launch in the European Union

Jan 10, 2016, 07:00 ET from AcelRx Pharmaceuticals, Inc.

REDWOOD CITY, Calif., Jan. 10, 2016 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced anticipated 2016 milestones for its product portfolio, including ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso (sufentanil sublingual tablet system, 15 mcg). Specifically, AcelRx's corporate goals in the upcoming year are as follows:

  • ARX-04 ER and Postoperative Study Completion. AcelRx has finalized the remaining clinical plans for ARX-04 for the treatment of moderate-to-severe acute pain in a medically supervised setting, following a recent pre-NDA meeting with the FDA. Enrollment in the current open-label study (SAP302) in the emergency room (ER) will be continued, and a new study, known as SAP303, is expected to be initiated in the first quarter of 2016 in postoperative patients with moderate-to-severe acute pain. SAP303 will focus on enrolling patients older than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. Both studies are expected to be completed in 2016.
  • ARX-04 NDA Submission. AcelRx intends to pursue an indication for ARX-04 of moderate-to-severe acute pain in a medically supervised setting. Assuming successful completion of the above studies, the company anticipates submitting the NDA for ARX-04 in the second half of 2016.
  • Zalviso Open-Label Phase 3 Study Initiation and Completion. The company continues to advance the regulatory process for Zalviso and has completed a protocol review with the FDA. The Phase 3 study (IAP312) will primarily measure the rate of device errors, including the failure to dispense medication as well as the incidence of misplaced or dropped tablets. AcelRx expects to initiate the study in the first quarter of 2016.
  • Zalviso NDA Submission. Pending timely completion of the IAP312 study, AcelRx expects to resubmit the NDA for Zalviso before the end of 2016.
  • Zalviso EU Commercial Launch. In September 2015 the European Commission approved Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. The marketing authorization was granted for the 28 EU member states as well as for the European Economic Area countries, Norway, Iceland and Liechtenstein. Grunenthal Group, AcelRx's licensee in Europe, will be working with the member states of the EU and EEA to ensure that Zalviso is made available to those patients who would benefit from an effective and reliable solution for their acute moderate-to-severe post-surgical pain. The companies expect the product to be available to Western European patients in the first half of 2016.

"Our interactions with the FDA have been productive and have provided guidance for meeting the FDA's requirements for submitting an NDA for ARX-04 and the resubmission of an NDA for Zalviso," stated Howie Rosen, interim CEO of AcelRx. "With this clarification on the regulatory pathways, our focus in 2016 will be on execution. Pending positive and timely results from our clinical studies, we anticipate NDA submissions this year for both of our lead products.  We also are actively manufacturing supplies to support the launch of Zalviso in Europe by our partner Grunenthal. Should we achieve the milestones that we have laid out for ourselves, 2016 will be a pivotal year for AcelRx."

Members of AcelRx senior management will be participating in The Trout Group Annual 1x1 Management Access Event in San Francisco, January 11 – 14, 2016.

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain. The company's late-stage pipeline includes ARX-04 for the treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso for the management of moderate-to-severe acute pain in adult patients in the hospital setting. ARX-04 delivers 30 mcg sufentanil, a high therapeutic index opioid, sublingually through a disposable, pre-filled, single-dose applicator. AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and has advanced ARX-04 into a study (SAP302) in emergency room patients. In addition, AcelRx intends to initiate SAP303 in the first quarter of 2016, with a focus on enrolling patients greater than 40 years of age, allowing for administration of ARX-04 for up to 12 hours.

AcelRx' other late stage development product, Zalviso, delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. In response to the New Drug Application (NDA) AcelRx submitted to the U.S. Food and Drug Administration (FDA) seeking approval for Zalviso, AcelRx received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an additional clinical study (IAP312), which AcelRx is planning to initiate in the first quarter of 2016, to support resubmission of the NDA.

For additional information about AcelRx's clinical programs, please visit www.acelrx.com.

Forward Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidates, including the process and timing of anticipated future development of Zalviso and ARX-04; timing for initiation and completion along with anticipated results of IAP312 for Zalviso; anticipated results and timing of the completion of the SAP302 and SAP303 studies for ARX-04; launch timing and commercial availability for Zalviso in Europe; AcelRx's plans to seek a pathway forward towards gaining approval of Zalviso in the United States; and anticipated resubmission of the Zalviso NDA to the FDA, including the scope and timing of resubmission. These forward-looking statements are based on AcelRx's current expectations and inherently involve significant risks and uncertainties. AcelRx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: any delays or inability to obtain and maintain regulatory approval of its product candidates, including Zalviso and ARX-04; its ability to successfully design and complete the additional clinical study requested by the FDA to support resubmission of the Zalviso NDA; its ability to timely resubmit the Zalviso NDA to the FDA and to receive regulatory approval for Zalviso; the fact that the FDA may dispute or interpret differently positive clinical results obtained to date from the pivotal Phase 3 SAP301 ambulatory surgery study of ARX-04; its ability to complete Phase 3 clinical development of ARX-04; the success, cost and timing of all product development activities and clinical trials, including the SAP302 and SAP303 ARX-04 trials and the IAP312 Zalviso trial; ability to manufacture commercial supply of Zalviso; 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 3, 2015. 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.

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SOURCE AcelRx Pharmaceuticals, Inc.



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