Stock Update (NASDAQ:ACRX): AcelRx Pharmaceuticals Inc Presents Data from Phase 3 Clinical Trials Evaluating the Safety and Efficacy of Zalviso in Obese Surgical Patients

AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, will be presenting at ObesityWeek 2015 an analysis from three Phase 3 studies showing that Zalviso™ (sufentanil sublingual tablet system 15 mcg) provides a faster onset of pain relief in obese (BMI ≥ 30 kg/m2) post-surgical patients than intravenous (IV) patient-controlled analgesia (PCA) with morphine. Specifically, patients who self-administered Zalviso experienced statistically significantly improved pain relief when compared to self-administered IV morphine as measured by pain intensity difference to baseline (PID).  Significant differences in PID were observed as early as 45 minutes after the first dose (p<0.05), a trend that continued until six hours after the initial dose (p<0.001), after which time PID scores equilibrated between the two groups.

“Both of our lead products, Zalviso and ARX-04 (a double-strength dose of sublingual sufentanil 30 mcg administered by a nurse) benefit from sufentanil’s lipophilic nature,” said Dr. Pamela Palmer, AcelRx Co-founder and Chief Medical Officer.  “Lipophilic, or fat-soluble drugs, typically produce rapid drug uptake from mucosal tissues into the plasma and then into the brain, promoting minimal delay between dosing and pain relief.  Nurse-administered ARX-04 dosing is designed to address more short-term moderate-to-severe pain treatment. For 2 or 3-day inpatient stays, Zalviso allows patients to self-titrate regardless of body mass so they are able to achieve their individualized pain relief goals without the need for time-consuming dose-adjustments from hospital staff.”

Results of the sub-group analysis presented by AcelRx also show that obese patients who administered Zalviso experienced statistically fewer adverse events than did those receiving IV PCA morphine.  While overall adverse event rates were comparable, incidence rates of anemia, leukocytosis (increase in white blood cells), vomiting, hypoalbuminemia (decrease in albumin levels), hyponatremia (decrease in sodium levels), urinary retention and pruritus (itching) were all significantly lower in the Zalviso arm compared to the morphine arm (p≤0.05).

Dr. Palmer continued, “We believe that the non-invasive route of administration of Zalviso and ARX-04 sets these drugs apart from analgesics requiring an IV line which can be associated with increased infection risk and decreased mobility. Obese postoperative patients suffer from an increased physiological risk, as well as difficult IV access, and we want to make every effort to keep these patients ambulatory in order to avoid post-operative complications, such as partial lung collapse, deep vein thrombosis, and pulmonary embolism.”

Complete results titled “Efficacy and Safety of the Sufentanil Sublingual Tablet System (SSTS) in Class I and II Obese Patients: The Effect of BMI on Analgesic Response” will be presented during ObesityWeek 2015, being held inLos Angeles, CA, from November 2-6, 2015.  ObesityWeek is a unique, international event with more than 5,200 attendees from 73 countries focused on the basic science, clinical application, surgical intervention and prevention of obesity. By combining both the American Society for Metabolic & Bariatric Surgery (ASMBS) and The Obesity Society(TOS) annual meetings, ObesityWeek brings together world-renowned experts in obesity to share innovation and breakthroughs in science unmatched around the globe. (Original Source)

Shares of Acelrx Pharmaceuticals closed yesterday at $4.52. ACRX has a 1-year high of $9.32 and a 1-year low of $2.92. The stock’s 50-day moving average is $3.59 and its 200-day moving average is $3.92.

On the ratings front, Acelrx has been the subject of a number of recent research reports. In a report issued on October 30, Jefferies Co. analyst Biren Amin assigned a Buy rating on ACRX, with a price target of $7, which represents a potential upside of 54.9% from where the stock is currently trading. Separately, on October 8, Cowen’s Boris Peaker reiterated a Hold rating on the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Biren Amin and Boris Peaker have a total average return of 11.3% and 22.2% respectively. Amin has a success rate of 57.8% and is ranked #377 out of 3824 analysts, while Peaker has a success rate of 47.1% and is ranked #116.

The street is mostly Bullish on ACRX stock. Out of 4 analysts who cover the stock, 3 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $8.67, which represents a potential upside of 91.8% from where the stock is currently trading.

AcelRx Pharmaceuticals Inc is a specialty pharmaceutical company. The Company is engaged in the development and commercialization of therapies for the treatment of acute pain.

Stay Ahead of Everyone Else

Get The Latest Stock News Alerts