AcelRx Pharmaceuticals Inc (ACRX) Announces Key Results from Phase 3 Study of ZALVISO


AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) reported key results from the Phase 3 IAP312 study of ZALVISO® (sufentanil sublingual tablet system), an investigational product candidate being developed for the management of moderate-to-severe acute pain in adult patients in a hospital setting. Throughout the study in 320 enrolled patients, 2.2% of patients experienced a ZALVISO device error, which was statistically less than the 5% limit specified in the study objectives. Importantly, none of these device errors resulted in an over-dosing event. This 2.2% rate was lower (p < 0.001) than the 7.9% rate of device errors during patient use previously reported for the earlier version of the ZALVISO device in the Phase 3 IAP311 study.

In addition, as requested by FDA, the IAP312 study prospectively evaluated the number of inadvertently misplaced tablets which occurred during patient dosing. A small number of inadvertently misplaced tablets (less than 0.1% of total dispensed tablets) was observed in the original Phase 3 studies. However, the presence of inadvertently misplaced tablets had not been routinely assessed as part of the previous protocols. The ZALVISO System allows patients to self-administer a 15 mcg sufentanil sublingual tablet as often as once every 20 minutes as needed for pain control. Throughout the IAP312 study, patients self-administered a total of 7,293 sufentanil tablets. Per the updated ZALVISO training instructions electronically displayed on the hand-held device, 6 patients called the nurse when they failed to properly self-administer a single tablet to allow for proper retrieval and disposal of the tablet. Also, during inspection by the nurse, which occurred every two hours per protocol, a total of 7 misplaced tablets (<0.1% of total dispensed tablets) were discovered with 6 additional patients. No patient had a repeat incidence of an inadvertently misplaced tablet following re-training on the device. This combination of patient training and nurse inspection, along with the tracking features of the ZALVISO device, could potentially address the FDA’s concerns regarding drug accountability.

Finally, in this study, 86%, 89% and 100% of patients at the 24, 48 and 72-hour time points, respectively, recorded “good” or “excellent” ratings on the patient global assessment (PGA) of the method of pain control, which measures a patient’s satisfaction with their quality of analgesia. Healthcare professional global assessment (HPGA) of the method of pain control was similarly strong, with 91%, 95% and 100% of nurses rating ZALVISO as “good” or “excellent” over each respective 24-hour period. ZALVISO was shown to be well tolerated by study participants, with nausea, hypotension and vomiting representing the most commonly reported adverse events. A total of 5 patients experienced serious adverse events, but all were considered unrelated to study drug by investigators.

Dr. Pamela Palmer, AcelRx co-founder and chief medical officer commented, “It is important that hospitalized patients suffering from moderate-to-severe acute pain have options for self-titrating their analgesic medications to target their individual pain levels. IAP312 demonstrated high levels of patient and nurse satisfaction with the ZALVISO System, which is both non-invasive and pre-programmed. Our expectation is that results from this IAP312 study will provide the FDA with a more complete picture of ZALVISO’s functionality and usability. We intend to submit these results, together with our earlier Phase 3 studies – IAP309, IAP310 and IAP311, which met safety and efficacy endpoints as part of our resubmission of a New Drug Application to the FDA by the end of 2017.”

In addition, Dr. Harold Minkowitz, a principal investigator in IAP312 as well as the previous ZALVISO Phase 3 trials, and an anesthesiologist at Memorial Hermann Memorial City Medical Center in Houston stated, “The pre-programmed nature of ZALVISO may help mitigate human factor-related errors associated with analgesic dosing that potentially increase morbidity and mortality. The highly favorable patient and HCP satisfaction scores reported for the entire study corroborate my patients’ and staff’s experience with the ZALVISO System. If approved, ZALVISO could provide physicians and patients a non-invasive, patient-controlled analgesia system for acute pain treatment in the hospital setting.”

Shares of Acelrx Pharmaceuticals are down nearly 6% to $3.65 in pre-market trading Tuesday. ACRX has a 1-year high of $4.08 and a 1-year low of $1.95. The stock’s 50-day moving average is $2.62 and its 200-day moving average is $2.76.

On the ratings front, Acelrx has been the subject of a number of recent research reports. In a report issued on July 25, Piper Jaffray analyst David Amsellem reiterated a Hold rating on ACRX, with a price target of $3.00, which reflects a potential downside of 23% from last closing price. Separately, on July 14, Jefferies’ Matthew Andrews assumed coverage with a Buy rating on the stock and has a price target of $7.00.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, David Amsellem and Matthew Andrews have a yearly average loss of 0.4% and a return of 10.9% respectively. Amsellem has a success rate of 45% and is ranked #3510 out of 4627 analysts, while Andrews has a success rate of 47% and is ranked #986.

Overall, 2 research analysts have assigned a Hold rating and 3 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $7.00 which is 79.5% above where the stock closed yesterday.

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company, which engages in the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. Its product candidates is comprised of DSUVIA, and ZALVISO, which both contains sufentanil as a therapeutic ingredient.