AcelRx (ACRX) ARX-04 Well-Positioned for Approval - H.C. Wainwright

H.C. Wainwright analyst Ed Arce affirmed a Buy rating and $7 price target on AcelRx Pharmaceuticals (NASDAQ: ACRX) ahead of NDA Filing of ARX-04 this month. An expert panel highlighted that ARX-04 is well-positioned for approval, the analyst notes.

Acre commented, "Last week, on December 1, we attended AcelRx's investor meeting featuring the clinical data presented by Dr. David Leiman of Hermann Drive Surgical Hospital, as well as an overview of the commercial opportunity of ARX-04 presented by Gina Ford, Vice President of Commercial Operations at AcelRx. In addition, the program for this Analyst's Day included a panel discussion featuring Dr. James Miner, Chief of Emergency Medicine at Hennepine County Medical Center in Minneapolis, Dr. Michael Ritter, Emergency Department and Medical Director at Mission Hospital at Mission Viejo, California, and Dr. John Holocomb, Director of the Center of Translational Injury Research who provided insight on pain management in military settings based on his 23-year experience in the army. Notably, all experts view ARX-04 as well-posited for first-pass approval for a number of reasons. First, ARX-04 demonstrated robust efficacy by not only achieving the primary and secondary endpoints across four separate studies (SAP202, SAP301, SAP302, SAP303) but also achieved consistent differences from placebo in the Summed Pain Intensity Difference to baseline through 12 hours (SPID12), the primary efficacy endpoint of pain trials as requested by FDA (Exhibit 1 and 2). Second, experts emphasized the 3-point reduction in pain intensity difference (PID) within 60 minutes observed in the SAP302 trial (conducted in 76 patients in ER settings and depicted in Exhibit 3), when a 1.0 to 1.5-point reduction is considered clinically meaningful, reflects the robustness of the efficacy. In addition, statistically significant reductions in pain intensity versus placebo were evident within 15 to 30 minutes for SAP202 (p<0.001 at 30 min) and SAP301 (p=0.002 at 15 min) as well as for the open-label studies SAP302 and SAP303. Third, the featured physicians were impressed by the remarkably clean safety profile of the drug with 79% of patients exhibited no side effects across all ARX-04 Phase 2 and Phase 3 studies. The most common adverse events reported included nausea, vomiting, headache, and dizziness, as depicted in Exhibit 4. In addition, ARX-04 does not impair cognitive functions as measured by the Six-Item Screener (a validated questionnaire that asks the patients to recall three items as well as three temporal orientations) upon request by the DoD. Dr. Holcomb who has served as a trauma surgeon and has led the DoD laboratory devoted to combat casualty care in the army for two decades pointed out that cognitive impairments are a major concerns with other field-based analgesics used in the military, such as shock due to peripheral vasoconstriction, fentanyl lozenge taking over 30 min to dissolve, and ketamine with dissociative effects (cognitive dysfunction with episodic and semantic memory). He perceives that the absence of such cognitive symptoms combined with a clean safety profile of ARX-04 makes it a superior therapeutic option in military-based settings. Given the strong support from four leading pain experts who have treated thousands of patients and have been involved a plethora of pain trials enhances our confidence for approval of ARX-04 for the treatment of moderate-to-severe pain, and thereby we affirm our Buy rating."

For an analyst ratings summary and ratings history on AcelRx Pharmaceuticals click here. For more ratings news on AcelRx Pharmaceuticals click here.

Shares of AcelRx Pharmaceuticals closed at $2.75 yesterday.

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