A Study of TRV130 for the Treatment of Pain After Bunionectomy

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with
placebo in patients with acute postoperative pain after bunionectomy. Additional objectives
are to evaluate the efficacy and safety of TRV130 compared to morphine. Pharmacokinetics of
TRV130 and morphine will be evaluated.

Inclusion Criteria:

- Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and
internal fixation) with no additional collateral procedures.

- Experiences a pain intensity rating of ≥ 4 on an 11 point NRS

- Able to provide written informed consent before any study procedure.

Exclusion Criteria:

- ASA Physical Status Classification System classification of P3 or worse

- Has surgical or post-surgical complications.

- Has clinically significant medical conditions or history of such conditions that may
interfere with the interpretation of efficacy, safety, or tolerability data obtained
in the trial, or may interfere with the absorption, distribution, metabolism, or
excretion of drugs.

- Has previously participated in another TRV130 clinical study.