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AcelRx Pharmaceuticals Announces Initiation Of Pivotal Phase 3 Trial For ARX-04
This study, SAP301, is a multi-center, double-blind, placebo-controlled study that will evaluate the efficacy and safety of ARX-04 vs. placebo for the treatment of moderate-to-severe acute pain following ambulatory abdominal surgery. SAP301 is expected to include approximately 160 adult patients, randomized 2:1 active to placebo, to be treated for up to 48 hours. ARX-04 or placebo will be administered by site staff as requested by the patient, but no more than once per hour. The primary endpoint of the study is to demonstrate a statistically significant difference in the time-weighted summed pain intensity difference (
"We are pleased to have our pivotal ARX-04 Phase 3 clinical trial underway. The ARX-04 product represents a promising new application of our sublingual tablet technology for delivery of sufentanil and has the potential to safely provide non-invasive, fast-acting analgesia for patients in acute pain," stated Dr.
The ARX-04 SDA is a non-invasive, single-use, disposable, handheld applicator that allows healthcare professionals to effectively administer tablets to a patient's sublingual space to manage their moderate-to-severe acute pain. ARX-04 consists of a 30 mcg sufentanil sublingual tablet, in a pre-filled SDA. AcelRx's proprietary tablet formulation enables sublingual sufentanil absorption when ARX-04 is placed under the tongue. As a result, ARX-04 can provide analgesia in a non-invasive method of administration and display a consistent pharmacokinetic profile due to a high percentage of drug being absorbed sublingually instead of through the gastrointestinal tract. We believe ARX-04 may be a candidate for use in a variety of medically supervised settings to manage moderate-to-severe pain, including in the emergency room, or for post-operative patients, following either short-stay or ambulatory surgery, who do not require more long-term patient-controlled analgesia, as well as for battlefield casualty treatment, and by paramedics during patient transport. According to the National Emergency Department Sample, there were more than 104 million adult emergency room visits in the U.S. during 2011, of which it is estimated that more than 48 million were associated with moderate-to-severe acute pain; while in the EU-5 there were more than 91 million adult emergency room visits during 2011, of which it is estimated that more than 34 million were associated with moderate-to-severe acute pain.
About Acute Pain
In situations of trauma or injury, it is advantageous to have a rapid-acting, non-invasive method of treating acute pain. In the emergency room and in ambulatory care environments, or on the battlefield, patients often do not have immediate intravenous, or IV, access available, or maintaining IV access can be an impediment to rapid discharge. Oral pills and liquids generally have slow and erratic onset of analgesia. 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 that can safely and rapidly treat acute trauma pain, in both civilian and military settings.
This press release contains forward-looking statements, including, but not limited to, statements related to the completion of enrollment in SAP-301, the Company's first Phase 3 clinical trial for ARX-04, the anticipated timing of top-line results from SAP-301, regulatory approval of ZalvisoTM, and the therapeutic and commercial potential of
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Timothy E. Morris, Chief Financial Officer, 650.216.3511, firstname.lastname@example.org, Brian Korb, The Trout Group LLC, 646.378.2923, email@example.com