AcelRx Pharmaceuticals, Inc. (ACRX)
Q4 2012 Earnings Call
March 12, 2013, 04:30 pm ET
Jim Welch - CFO
Richard King - President & CEO
David Amsellem - Piper Jaffray
Louise Chen - Guggenheim Partners
Dana Flanders - Canaccord Genuity
Ed Arce - MLV & Company
John Newman - JMP Securities
Mario Corso - Mizuho Securities
Nick Farwell - Harbor Group
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I would now like to turn the call over to Mr. Jim Welch, Vice President and Chief Financial Officer. Mr. Welch, please go ahead.
Thank you, Amy. Good afternoon and welcome to today's call. This is Jim Welch and joining me on the call today is Richard King, AcelRx’s President and CEO. Earlier today, AcelRx issued its fourth quarter and full-year 2012 financial results which we will discuss in more detail on this call.
In addition, we will also provide you with a corporate update and a review of our progress on our Phase 3 clinical trial with our Sufentanil NanoTab Patient-Controlled Analgesia System that is being evaluated for the treatment of moderate to severe post-operative pain in the hospital as well as an update of our progress on our Phase 2 clinical trial for ARX-04, the Sufentanil NanoTab formulation to treat acute pain. These financial results press release has been posted to the website at www.acelrx.com. Also, a replay of this conference call will be available later today on the Investor Relations section of our website.
Please keep in mind that risks and uncertainties involved in the company's business may affect the matters referred to in forward-looking statements made by management during today's call. As a result, the company's performance may differ from those expressed and/or indicated by such forward-looking statements which are qualified in their entirety by the cautionary statements contained in the press release and in the company's Securities and Exchange Commission filings.
With this, I will now turn the call over to Richard King for a company overview.
Thanks Jim and welcome everybody to this afternoon’s call. AcelRx continues to make progress across multiple aspects of its business and I am pleased to provide you with an update on that progress today.
We have successfully completed two of our three Phase 3 studies for our lead products; the Sufentanil NanoTab Patient-Controlled Analgesia or PCA system with achievement of the primary endpoint attained in both cases. The third Phase 3 should complete shortly with topline data results expected in the same quarter of 2013. In addition, we have completed patient dosing in our Phase 2 trial with ARX-04, a single dose Sufentanil NanoTab product for treating acute pain that is being funded entirely via grant from the Department of Defense with data from this study anticipated in the second quarter of 2013.
I would like to briefly review results from the two Phase 3 studies announced so far for the NanoTab System. In November of 2012, we announced the topline results from our first Phase 3 NanoTab System trial, an open-label trial that directly compared the NanoTab System to IV PCA with morphine. This study was conducted in patients after even major abdominal or major orthopedic surgeries with 359 patients randomized to receive either Sufentanil NanoTabs of IV PCA with morphine. This study achieved its primary endpoint demonstrating that the NanoTab System is not inferior to IV PCA with morphine for the primary endpoint of Patient Global Assessment, a method of pain control. In addition, because the results was strongly in favor of the NanoTab System, a statistical analysis for superiority could be performed which demonstrates that the NanoTab System was specifically superior to IV PCA with morphine for the Patient Global Assessment endpoint in this trial.
We also collected and report a large amount of secondary endpoint data in this study. In particular, conclusions from validated ease-of-care questionnaires configured by both patients and nurses during and at the end of the study point to superiority in favor of the NanoTab System over IV morphine for both satisfaction and ease-of-care for both nurses and patients alike. The takeaway is that nurses identified the NanoTab System as less bothersome to set up and monitor than IV PCA. In addition, patients reported that they have high confidence in the NanoTab System, that they ambulate more easily than when they were tethered to an IV PCA pump and that they achieved better pain control from the NanoTab System than with IV PCA with morphine.
In light of the fact that hospitals are very focused on achieving high patient satisfaction, since Medicaid and Medicare reimbursement and patient throughput are linked to this measure, we believe that the performance of the NanoTab System in this study suppose prospects for commercial adoption once we have received regulatory approval.
Outline results for our second Phase 3 and so it’s pivotal study were announced a week ago. In this trial a total of 178 patients following open abdominal surgery were randomized to the NanoTab System droving Sufentanil NanoTabs, or the NanoTab System delivering placebo NanoTabs in a two to one randomization. This study achieved its primary endpoint demonstrating that the NanoTab System achieved significantly greater Summed Pain Intensity Difference over 48 hours or SPID-48 as it is commonly called during the study period in placebo treated patients. Secondary endpoint data also showed significant superiority for SPID-48 in the Sufentanil treated patients at 24 and 72 hours after the first dose compared to placebo-treated patients.