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AcelRx Pharmaceuticals' ARX-04 Meets all Endpoints in Pivotal Phase 3 Study for Moderate-to-Severe Acute Pain
"These results bring AcelRx one step closer to commercializing a sublingual sufentanil product that we believe will have a meaningful impact by providing a non-invasive treatment of moderate-to-severe acute pain in several medically supervised settings," said Dr.
The Phase 3 SAP301 trial enrolled adult patients undergoing outpatient abdominal surgery procedures at four clinical sites in
The primary endpoint of the study was the difference in the
There were two serious adverse events (SAEs) reported during the study period, both of which were in the placebo group and resulted in early termination of the affected patients. No patient in the ARX-04 group dropped out of the study prior to 24 hours due to an adverse event. A lower percent of patients treated with ARX-04 dropped out of the study prior to 24 hours due to lack of efficacy compared to the placebo group (3.7% and 18.5%, respectively; p=0.002).
"In addition to the ambulatory surgery setting studied in this trial, we believe ARX-04 has broad application in emergency room and military settings, where patients often do not have immediate access to IV pain medications," added
ARX-04 is an investigational product candidate consisting of sufentanil sublingual tablets, 30 mcg, delivered via a disposable, pre-filled, single-dose applicator (SDA). AcelRx is developing ARX-04 for the management of moderate-to-severe acute pain in a variety of medically supervised settings, including in the emergency room, for outpatient or ambulatory surgery, for non-surgical patients experiencing pain in the hospital, or for post-operative patients, following short-stay surgery, who do not require more long-term patient-controlled analgesia (PCA). Based on its market research, the Company estimates there are more than 51 million injury-related emergency department visits annually that on average receive 2 doses of opioids for moderate to severe pain in
About Acute Pain
In situations of trauma or injury, it is advantageous to have a non-invasive method of treating acute pain. In the battlefield, in the emergency room and in ambulatory care environments, patients often do not have immediate intravenous, or IV, access available. Intramuscular injections are the current standard of care on the battlefield, but they are invasive, painful, and present an increased risk of infection to both patient and healthcare professional. In addition, in cases of severe trauma where the patient is often in hypovolemic shock and muscles are not well perfused, pain medication given by intramuscular injection may not readily reach the blood stream to provide pain relief, rendering this route of delivery suboptimal. Oral pills and liquids generally have erratic onset of analgesia. Moreover, IV dosing results in high peak plasma levels, thereby limiting the opioid dose and requiring frequent redosing intervals to titrate to satisfactory analgesia. Additional treatment options are needed which can safely and effectively treat acute pain, in both civilian and military settings.
ARX-04 delivers 30 mcg sufentanil sublingual, a high therapeutic index opioid, through a disposable, pre-filled, single-dose applicator (SDA). AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and will be advancing ARX-04 into a study in emergency room patients in 2015. Zalviso delivers 15 mcg sufentanil sublingual through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. In response to the New Drug Application (NDA) AcelRx submitted to the
The Company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
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Timothy E. Morris, Chief Financial Officer, 650.216.3511, email@example.com, Brian Korb, The Trout Group LLC, 646.378.2923, firstname.lastname@example.org