• AcelRx Pharmaceuticals (ACRX) Phase 3 Results of ARX-04 for Acute Pain

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    Clinical and Regulatory
    Event Type: Phase 3 Results
    Timing: Q3 2016
    Designation(s): None

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Other
    Indication: Acute Pain
    Lead Indication?: No
    Treatment Name: ARX-04

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: AcelRx Pharmaceuticals
    Stock Symbol: ACRX
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Positive
    Event Discussion: Forums
    Event Announcement(s): http://ir.acelrx.com/phoenix.zhtml?c=241441&p=irol-newsArticle&cat=news&id=2202007
    Partnership: No

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement


    REDWOOD CITY, Calif. ,  Sept. 15, 2016  /PRNewswire/ --  AcelRx Pharmaceuticals, Inc.  (NASDAQ: ACRX) today announced that in an open-label Phase 3 trial (SAP303), investigational product candidate ARX-04 (sufentanil sublingual tablet 30 mcg) was well tolerated in the management of moderate-to-severe acute pain in post-operative study patients, including elderly patients and those with organ impairment. Regardless of age and organ function, approximately 2 in 3 patients had no adverse events during the study (63% of all patients, 63% of those aged ≥65 years, 62% of those with hepatic impairment, 70% of those with renal impairment). The most common adverse events were nausea and headache. On a global assessment of ARX-04 as a method of pain control, 90% of healthcare professionals and 87% of patients responded "good" or "excellent."


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