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Last $3.34 USD
Change Today -0.03 / -0.89%
Volume 279.9K
ACRX On Other Exchanges
As of 8:10 PM 10/5/15 All times are local (Market data is delayed by at least 15 minutes).

acelrx pharmaceuticals inc (ACRX) Snapshot

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02/26/15 - $9.32
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acelrx pharmaceuticals inc (ACRX) Details

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company, develops and commercializes therapies for the treatment of acute pain. The company’s lead product candidate is Zalviso, an investigational, pre-programmed, non-invasive, handheld system that has completed Phase III clinical trials for the treatment of moderate-to-severe acute pain in the hospital setting. The company is also developing ARX-04, a sufentanil single-dose tablet, which has been planned to initiate Phase III clinical trials for the treatment of moderate-to-severe acute pain to be administered by a healthcare professional to a patient in settings of acute pain, such as in the emergency room, hospital floor, ambulatory care facilities, or on the battlefield. In addition, its product candidate pipeline consists of ARX-02, a pain management system that has completed Phase II clinical trials for the treatment of cancer patients who suffer from breakthrough pain; and ARX-03, a single, fixed-dose, and combination drug product, which has been completed Phase II clinical trial designed to provide mild sedation, anxiety reduction, and pain relief for patients undergoing painful procedures in a physician’s office. The company was formerly known as SuRx, Inc. and changed its name to AcelRx Pharmaceuticals, Inc. in August 2006. AcelRx Pharmaceuticals, Inc. was founded in 2005 and is headquartered in Redwood City, California.

33 Employees
Last Reported Date: 08/4/15
Founded in 2005

acelrx pharmaceuticals inc (ACRX) Top Compensated Officers

Co-Founder, Chief Medical Officer and Directo...
Total Annual Compensation: $421.0K
Chief Financial Officer and Head of Business ...
Total Annual Compensation: $288.4K
Chief Development Officer
Total Annual Compensation: $310.3K
Chief Engineering Officer
Total Annual Compensation: $310.3K
Compensation as of Fiscal Year 2014.

acelrx pharmaceuticals inc (ACRX) Key Developments

AcelRx Pharmaceuticals, Inc. Appoints Gina Ford as Vice President Commercial Strategy

AcelRx Pharmaceuticals, Inc. announced the appointment of Gina Ford, RPh to the role of Vice President of Commercial Strategy. Ms. Ford has worked with AcelRx as a consultant from 2013 to the present and has been instrumental in the development of a commercial strategy for Zalviso (sufentanil sublingual tablet system). As VP Commercial Strategy, Ms. Ford will be responsible for developing the commercial plan for ARX-04 in the U.S., Europe and other geographies. Before joining the AcelRx management team, Ms. Ford was principal and sole proprietor of One Joule.

European Commission Grants Marketing Authorization for AcelRx Pharmaceuticals, Inc.'s Zalviso for Treatment of Acute Moderate-to-Severe Post-Operative Pain in Adult Patients

AcelRx Pharmaceuticals, Inc. announced that the European Commission has approved Zalviso (15 micrograms sufentanil sublingual tablets) for the management of acute moderate-to-severe post-operative pain in adult patients. The marketing authorization is granted for the 28 EU member states as well as for the European Economic Area (EEA) countries, Norway, Iceland and Liechtenstein. Zalviso is a system combining a drug and a device designed to deliver a sublingual tablet formulation of sufentanil 15 mcg via a proprietary, pre-programmed, non-invasive, patient-controlled analgesia (PCA) device. Grunenthal Group, AcelRx's licensee in Europe and Australia, expects the product to be available to Western European patients in the first half of 2016. Zalviso is designed to offer sustained (for up to 72 hours) and reliable pain relief for acute moderate-to-severe post-operative pain. In a Phase 3 clinical trial in patients who had undergone major joint replacement or open abdominal surgery, a higher percentage of study participants who self-administered Zalviso over a 48-hour period rated the method of pain control "good" or "excellent" compared to those using intravenous (IV) morphine PCA (p=0.007). Moreover, patients surveyed in this study rated their overall ease of care (p<0.001) and overall satisfaction (p=0.004) with Zalviso as higher than with IV morphine PCA. Zalviso was also rated by nurses to provide higher treatment satisfaction (p<0.001) and overall ease of care (p=0.017) compared with IV morphine PCA. Adverse events reported in the study were generally mild or moderate in nature and similar in both placebo and treatment groups, however fewer patients using Zalviso experienced oxygen desaturation episodes < 95% (p=0.028).

AcelRx Pharmaceuticals ARX-04 Meets All Endpoints in Pivotal Phase 3 Study for Moderate-to-Severe Acute Pain

AcelRx Pharmaceuticals, Inc. announced that ARX-04 met primary and secondary endpoints in a multi-center, double-blind, placebo-controlled Phase 3 trial (SAP301) designed to study the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery. Results demonstrated that patients receiving ARX-04, administered via a disposable, pre-filled, single-dose applicator (SDA), experienced significantly greater pain reduction compared to placebo, as measured by the time-weighted summed pain intensity difference over the first 12 hours of treatment (SPID-12)(p<0.001). Adverse events reported in the study were typical of opioid therapy and were similar for patients treated with ARX-04 and placebo, the most common of which were nausea, headache and vomiting. The Phase 3 SAP301 trial enrolled adult patients undergoing outpatient abdominal surgery procedures at four clinical sites in the United States. Following surgery, 163 patients were randomized to receive either ARX-04 or placebo in a 2:1 active to placebo ratio. ARX-04 or placebo was administered by site staff as requested by the patient, but no more than once per hour. The intent-to-treat (ITT) population in this study averaged 40.9 years of age with an average Body Mass Index of 27.5, and had a higher percent of females to males (68%:32%). 89% of patients entering the study completed the 24-hour study period. The primary endpoint of the study was the difference in the SPID-12 score of patients receiving ARX-04 compared to those receiving placebo. SPID-12 scores were +25.8 for ARX-04-treated patients and +13.1 for placebo-treated patients; the difference between the two groups being highly statistically significant (p<0.001). Notably, the difference in pain intensity from baseline was superior for ARX-04 over placebo at the earliest time point measured (15 minutes; p=0.002). Secondary efficacy endpoints, which will be presented in detail at the upcoming American Society of Anesthesiologists Annual Meeting, were also superior for ARX-04 compared to placebo.


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