Credit: Shutterstock photoAcelRx Pharmaceuticals, Inc.ACRX announced that it has dosed the first patient in a multi-center, double-blind, placebo-controlled phase III study (SAP301) on its investigational candidate, ARX-04 (30 mcg sufentanil sublingual tablet) for the treatment of moderate-to-severe acute pain following ambulatory abdominal surgery.
The SAP301 study, which is expected to enroll approximately 160 patients and randomize them 2:1 to receive either ARX-04 or placebo, will evaluate the efficacy and safety of ARX-04 in comparison to placebo. The primary endpoint of the study is to show a statistically significant difference in the time-weighted summed pain intensity difference between ARX-04 and placebo over a 12-hour dosing period.
AcelRx stated that patient enrolment should be completed by Dec 2015 with top-line data expected in the fourth quarter of 2015.
We note that Hospira's HSP Dyloject was recently approved for the management of mild-to-moderate pain and moderate-to-severe pain alone or in combination with opioid analgesics in the postoperative setting.
According to the press release issued by AcelRx, in situations of trauma or injury, a rapid-acting, non-invasive method of treating acute pain can be more efficient than intravenous or oral methods. Hence, additional treatment options are required in this field. The company believes that since ARX-04 is a non-invasive, single-use, sublingual tablet designed to be available in a disposable, pre-filled and single-dose applicator, it has the potential to treat acute trauma pain safely and rapidly.
Meanwhile, in Mar 2015, the FDA asked AcelRx to conduct an additional study on its lead candidate, Zalviso, to assess the risk of inadvertent dispensing and overall risk of dispensing failures. We remind investors that AcelRx had received a complete response letter (CRL) from the FDA for Zalviso on Jul 25, 2014 and conducted a bench test and two Human Factors studies in response to the CRL. The company said that it intends to meet the agency to clarify the need for an additional study and discuss the potential design and objectives of the same.
We expect investor focus to remain on updates from AcelRx.
AcelRx carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Lannett Company, Inc. LCI and Cytokinetics, Inc. CYTK . Both stocks carry a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
