Specialty pharmaceutical company AcelRx Pharmaceuticals’ dose-finding Phase II study of ARX-04 has met its primary endpoint.

ARX-04 is a rapid-onset, investigational single-dose sublingual sufentanil NanoTab, designed to treat acute pain.

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According to the data, patients in the 30mcg sufentanil NanoTab treatment group experienced significantly greater reduction in pain, as measured by Summed Pain Intensity Difference to baseline during the 12-hour study period (SPID-12), compared to placebo.

AcelRx Pharmaceuticals chief medical officer Dr Pamela Palmer said the goal of the programme was to measure the effective sublingual sufentanil dose administered less frequently by a healthcare professional than the patient-administered ARX-01 product candidate.

"ARX-04 is a rapid-onset, investigational single-dose sublingual sufentanil NanoTab, designed to treat acute pain."

"There is a need for a non-invasive, rapid-onset strong analgesic to provide short-term treatment of pain for the wounded soldier on the battlefield, the trauma victim at the site of a road-traffic accident, the migraine patient in the emergency room, or in general for patients in moderate-to-severe acute pain where intravenous access is not readily available," Palmer said.

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A total of 101 patients following bunionectomy surgery were randomised in 2:2:1 ratio to 30mcg sufentanil, 20mcg sufentanil or placebo treatment arms in the study.

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91% of patients completed the full 12-hour study period before entering the study.

SPID-12 scores for 30mcg sufentanil-treated patients were +6.53 and for placebo-treated patients -7.12, meaning the difference between the two groups was statistically significant.

The 20mcg sufentanil-treated patients failed to achieve SPID-12 scores that differentiated from placebo.

The study observed mild-to-moderate adverse events, while two serious adverse events of post-surgical infection that were unrelated to the study drug were reported.