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Analyst Shares 'Revelations from a Pooled Safety Analysis' of Pain Drug
Research Report

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An H.C. Wainwright & Co. report discussed the analgesic's safety profile and how it compares to an on-the-market competitor.

In a Jan. 15 research note, analyst Ed Arce reported the findings from an analysis of studies involving AcelRx Pharmaceuticals Inc.'s (ACRX:NASDAQ) DSUVIA and Zalviso, sufentanil sublingual tablets (SSTs). The analysis was published in Pain Management.

The specific aim of the study was to determine the safety of DSUVIA, or 30 mcg SST, in emergency room and postoperative patients, Arce explained. The analysis encompassed 804 patients, 646 of which had received the drug. For reference, one DSUVIA dose, or 30 microgram [mcg] SST, is considered bioequivalent to two Zalviso, or 2 15 mcg SSTs, given 20–25 minutes apart.

The study results, Arce relayed, showed 60.5% of patients who got DSUVIA and 61.4% of those who got a placebo reported experiencing adverse events.

Of those in the DSUVIA group who had side effects, 28.5% reported nausea, 6.5% reported vomiting and 5% reported headache, which, Arce noted, constitutes "a typical side effect profile of the opioid class."

He added, "We believe these findings support a comparatively benign overall safety profile for DSUVIA that is well tolerated, with most adverse events either mild or moderate in severity."

Arce highlighted three other conclusions from the published report. The first is that one DSUVIA dose is bioequivalent to a standard 5 milligram intravenous (IV) morphine dose. "This is critically important to understand in the context of DSUVIA as a highly potent opioid, as the effect of a drug's potency is meaningless in the absence of a given dose. In other words, while sufentanil is approximately five to 10 times more potent than its parent drug fentanyl and 500 times as potent as morphine, it is also true that a standard 5 mg dose of IV morphine is 167 times the dose of one DSUVIA or two Zalviso."

The second key point is that the analgesic, or pain relief, effect of Zalviso kicks in five times more quickly than it does with IV morphine. This was shown to be the case in a prior study of Zalviso (15 mcg SST patient-controlled analgesia [PCA]) versus IV morphine PCA after major orthopedic or open abdominal surgery. Clinically meaningful analgesia was seen after 1.3 hours with Zalviso compared to 7 hours with IV morphine.

The third important finding is that treatment with DSUVIA, in contrast to morphine, showed no evidence of cognitive impairment. "Morphine is commonly associated with cognitive adverse effects including impaired recall, delayed reaction time and impaired memory," Arce noted. In a prior DSUVIA study, in which 75 emergency room patients were evaluated for cognitive function before receiving the drug and at one hour after dosing, the cognitive scores of 97.3% of them stayed the same or improved after receiving the SST.

Finally, Arce presented three arguments for the use of DSUVIA over IV morphine. First, the potential for abuse via self-dosing is "largely eliminated" with DSUVIA because it must be administered in a "certified, medically supervised health care setting with a risk evaluation and mitigation strategy."

Second, the chance of accidental overdose is significantly lowered with DSUVIA as it comes in singly-packaged SST dispensing devices.

Third, because DSUVIA is administered sublingually (versus intravenously), dosing is more convenient, and symptom relief starts sooner, within six minutes as opposed to up to six hours.

H.C. Wainwright & Co. affirmed its Buy rating and its $9 price target on AcelRx Pharmaceuticals, whose stock is currently trading at around $2.48 per share.

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Disclosures from H.C. Wainwright & Co., AcelRx Pharmaceuticals Inc., First Take, January 15, 2019

I, Ed Arce and Thomas Yip , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) ne

None of the research analysts or the research analyst’s household has a financial interest in the securities of AcelRx Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of December 31, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of AcelRx Pharmaceuticals, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did receive compensation from AcelRx Pharmaceuticals, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for AcelRx Pharmaceuticals, Inc. during the past 12 months.

The Firm does not make a market in AcelRx Pharmaceuticals, Inc. as of the date of this research report.




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