AcelRx Pharmaceuticals Inc. (ACRX) announced top-line results demonstrating that a placebo-controlled, dose-finding, Phase 2 study of its investigational single-dose sublingual sufentanil NanoTab for acute pain, ARX-04, successfully met its primary endpoint.
The company said the results demonstrated that patients receiving 30 mcg sufentanil NanoTab doses, administered by a healthcare professional, no more frequently than once per hour, had significantly greater pain reduction as measured by Summed Pain Intensity Difference to baseline during the 12-hour study period or SPID-12 than placebo-treated patients (p=0.003).
According to the company, adverse events reported in the study were generally mild-to-moderate in nature, with two serious adverse events of post-surgical infection reported, both of which were determined by the investigator to be unrelated to study drug.
The company stated that two patients dropped out of the study due to adverse events, one patient's discontinuation considered unrelated to study drug, and the other considered probably related to study drug, both in the 30 mcg-treated group.
This study randomized 101 patients following bunionectomy surgery in a 2:2:1 ratio to 30 mcg sufentanil, 20 mcg sufentanil or placebo treatment arms. The intent-to-treat or ITT population in this study averaged 42.5 years of age with an average Body Mass Index of 28.2, and was evenly balanced for males and females (51%:49%) and ethnicity (54% Caucasian:46% non-Caucasian).
Ninety-one percent of patients entering the study completed the full 12-hour study period. SPID-12 scores were +6.53 for 30 mcg sufentanil-treated patients and -7.12 for placebo-treated patients, the difference between the two groups being highly statistically significant (p=0.003). The 20 mcg sufentanil-treated patients did not achieve SPID-12 scores that differentiated from placebo, the company said.
ARX-04 is a product candidate in development for the treatment of moderate-to-severe acute pain, consisting of sufentanil, a high therapeutic index opioid, in AcelRx's proprietary NanoTab technology that enables rapid sublingual absorption when the NanoTab is placed under the tongue.
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