AcelRx Announces FDA Acceptance of NDA for DSUVIA

In continuation of my update on  sufentanil

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 acceptance of its New Drug Application (NDA) resubmission for DSUVIA™ by the U.S. Food and Drug Administration (FDA). The FDA considers the DSUVIA NDA resubmission a complete class 2 response to their October 2017 action letter. Therefore, the FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 3, 2018.

The acceptance of the DSUVIA NDA resubmission is yet another important milestone achieved by the Company this year," stated Vince Angotti, Chief Executive Officer of AcelRx. "We are one step closer to potentially delivering a new, non-invasive treatment option for the management of moderate-to-severe acute pain for adult patients in medically supervised settings. We believe DSUVIA, if approved, also has the opportunity to help U.S. hospitals manage through the intravenous opioid shortage1 they are currently experiencing in their facilities," continued Angotti.

About DSUVIA™ (sufentanil sublingual tablet), 30 mcg

DSUVIA™ (sufentanil sublingual tablet, 30 microgram), known as DZUVEO™ outside the United States, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings, in adult patients and was designed to eliminate dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) administered by health care professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of DZUVEO. A decision by the European Commission on whether to grant the marketing authorization is expected in the third quarter of 2018.

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AcelRx Announces FDA Acceptance of NDA for DSUVIA

AcelRx Pharmaceuticals, Inc : Sufentanil

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 provided a regulatory update on Zalviso™ (sufentanil sublingual tablet system) intended for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The company has received formal minutes of the telephonic meeting held in early September 2015, with the Division of Anesthesia, Analgesia, and Addiction Products of the Food and Drug Administration (FDA). As reflected in the minutes, the Division restated at the meeting a request for clinical data to complement other data AcelRx has developed to assess the overall performance of the Zalviso device.

The company is planning to submit a protocol to the Division for a clinical study in post-operative patients designed to evaluate the effectiveness of changes made to enhance product performance. AcelRx expects to be ready to initiate the study in the first quarter of 2016, and likely will await comments on the protocol from the Division. The company will be prepared to work with the FDA to facilitate the timely study initiation.

"We have been preparing a clinical study to investigate the use of Zalviso in a more diverse post-surgical population than in our original Phase 3 studies," stated Pamela P. Palmer, MD, PhD, chief medical officer of AcelRx, "so we are modifying the design of this study to include endpoints that we believe will address the Division's concerns."

AcelRx Pharmaceuticals, Inc : Sufentanil

EMA CHMP considers AcelRx's ARX-04 for acute pain treatment for centralized review

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure. ARX-04 (sufentanil sublingual tablet, 30 mcg) is being developed for the treatment of moderate-to-severe acute pain in adult patients administered by a healthcare professional in a medically supervised setting.

ARX-04 is a non-invasive, fast-onset sufentanil product candidate under investigation.

"We appreciate the CHMP's consideration of ARX-04 for regulatory review under the centralized process, which we expect will make our planned MAA filing with the EMA much more efficient," commented Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx. "The EMA's centralized procedure is typically limited to products the EMA believes constitute significant therapeutic, scientific or technical innovations, characteristics we believe ARX-04 possesses."

For eligible drugs, the centralized procedure permits the submission of a single marketing application to the EMA that, if approved, allows the drug to be marketed in all 27 EU member states, as well as in the three European Economic Area (EEA) countries: Iceland, Liechtenstein and Norway.

ARX-04 is currently being studied in an open-label Phase 3 study (SAP302) in adult patients who present in the emergency room with acute moderate-to-severe pain associated with trauma or injury, and an additional Phase 3 study (SAP303) is planned in postoperative patients with acute moderate-to-severe pain. An earlier Phase 3 trial (SAP301) in patients with acute moderate-to-severe pain following ambulatory abdominal surgery demonstrated that patients administered ARX-04 experienced significantly greater pain relief compared to those receiving placebo, as measured by the time-weighted summed pain intensity difference over the first 12 hours of treatment (SPID12) (p<0.001). AcelRx expects to file marketing applications to both the EMA and the U.S. Food and Drug Administration (FDA) for ARX-04.

EMA CHMP considers AcelRx's ARX-04 for acute pain treatment for centralized review