cg or 15mcg of sufentanil.
Doses were delivered sublingually as needed to treat pain with a 20-minute
minimum re-dosing interval and patients were allowed to drop out of the study
at any time. Positive results were also obtained for the primary endpoint
following treatment with the 15mcg dose compared to placebo using two
alternate methods for imputing missing data from drop-outs: baseline
observation carried forward (BOCF), p = 0.007, and last observation carried
forward (LOCF), p = 0.018. Importantly, there were no events of clinically
significant respiratory depression for any dosing group. Based on these
positive results, AcelRx intends to further advance clinical development of
ARX-01 in 2009.
"We are pleased by the wonderful clinical results of our Phase 2
post-operative acute pain study," said Thomas A. Schreck, chairman and chief
executive officer of AcelRx Pharmaceuticals. "This is the culmination of a
great deal of hard work by a team of efficient, dedicated people over the last
two years, and is therefore very gratifying indeed. This trial has the benefit
of validating Sublingual Sufentanil NanoTabs as a robust product candidate for
its initial in-hospital acute pain indication, as well as providing the
foundation of safety and efficacy for the other programs in our pipeline."
About ARX-01 Sublingual Sufentanil NanoTabs
Sufentanil is currently approved as an intravenous (IV) anesthetic and is
also indicated for epidural administration during labor and delivery. Due to
their small size, ARX-01 Sublingual Sufentanil NanoTabs are convenient,
well-tolerated, have high bioavailability and provide lower peak plasma levels
compared to IV administration.
About the ARX-01 Oral Patient-Controlled Analgesia System
The ARX-01 Oral Patient-Controlled Analgesia (PCA) system is based on a
proprietary pre-programmed, hand-held dispenser being developed by AcelRx.
The AcelRx d
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