* A Phase 2, 185-patient randomized, placebo-controlled, dose-
escalation study in bunionectomy surgeries, which demonstrated
statistically significant reductions in average and worst pain scores
in the 1 mg Adlea dose group compared to placebo. In addition,
patients in the 1 mg Adlea group had a statistically significantly
longer median time to first use of an opioid or another acute pain
treatment compared to placebo. This Phase 2 trial is the basis for
the ongoing Phase 3 Adlea trial in bunionectomy surgeries, which
compares the same 1 mg Adlea dose to placebo control; the primary
endpoint in both trials is reduction in pain up to 32 hours post-
surgery for Adlea versus placebo.
* An exploratory clinical study in painful osteoarthritis of the knee
in which Adlea was generally well-tolerated, particularly when
stepwise dosing was used to reduce pain on injection in this non-
surgical setting. The study also generated longer-term data
suggesting reduced pain scores compared to baseline for up to the
eight week study endpoint.
* An independent presentation on long-term follow up from a study in
herniotomy surgeries which showed that, two years post-surgery, Adlea
treatment did not differ from placebo with regard to long-term
effects on sensory function in the surgical area.
* Preclinical studies suggesting that a single, clinically relevant
dose of Adlea does not have observable adverse effects on wound and
bone healing. A separate preclinical study demonstrated that a single
dose of Adlea caused a prolonged decrease in specific neuronal
markers and the TRPV1 receptor, suggestive of desensitization of the
nerve fibers, which gradually reversed
|SOURCE Anesiva, Inc.|
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