Zalviso is designed to deliver a sublingual formulation of an opioid, sufentanil, to adult patients with moderate-to-severe pain in a hospital setting using a hand-held, pre-programmed system. The device allows patients to self-administer sufentanil as often as once every 20 minutes.
In its 320-patient study, 2.2% patients experienced a device error – less than the 5% limit set in the study objectives. None of the reported errors caused an overdose, according to AcelRx. The device error rate is significantly lower than the 7.9% rate reported in a late-stage trial of the first-gen Zalviso device.
The Phase III trial also prospectively assessed the number of inadvertently misplaced tablets during patient dosing – a number that was requested by the FDA. Throughout the study, patients self-administered a total of 7,293 sufentanil tablets, according to AcelRx. The company reported that six patients alerted nurses when they did not properly self-administer a tablet, requesting proper retrieval and disposal.
Nurses inspected the study participants every two hours and reported that a total of seven tablets went missing across six patients throughout the study. After re-training on the device, no patient had a repeat incidence of misplacing a tablet, AcelRx reported.
At the 24, 48 and 72-hour time points, 86%, 89% and 100% of patients reported “good” or “excellent” ratings on an assessment that measures a patient’s satisfaction with their quality of pain relief.
“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,” co-founder & chief medical officer Dr. Pamela Palmer said in prepared remarks. “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.”
AcelRx’s Zalviso is cleared in the European Union, but is investigational in the U.S.
“The pre-programmed nature of Zalviso may help mitigate human factor-related errors associated with analgesic dosing that potentially increase morbidity and mortality,” principal investigator Dr. Harold Minkowitz added. “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 in AcelRx fell today after the company posted its second quarter financial results.
The Redwood City, Calif.-based company posted a loss of -$13.1 million, or -29¢ per share, on sales of $2.7 million for the 3 months ended June 30, for bottom-line loss of -18% on sales loss of -41% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -29¢, behind consensus on The Street, where analysts were looking for sales of $2.7 million.
“We are making solid progress on our path to commercializing our two late-stage product candidates, Dsuvia and Zalviso,” CEO Vincent Angotti said in prepared remarks. “We expect to receive a decision from the FDA on our marketing application for Dsuvia in the fourth quarter, and are on track to resubmit the NDA for Zalviso to the FDA that same quarter. We also continue to manage our expenses and cash in line with our plan leading into these major company milestones.”
ACRX shares were trading at $3.35 apiece today in morning activity, down -14.2%.