DURECT Reports Positive Phase IIb Data from TRANSDU(TM)-Sufentanil Clinic...(m toxicology and multiple biocompatibili...),Health

Phase IIb Trial

Objectives

• Primary objective: explore the minimally acceptable dose titration interval for transitioning opioid experienced patients to TRANSDUR-Sufentanil to achieve an acceptable analgesic and side effect profile.
• Secondary objectives:
  • Evaluate the relative potency relationship for converting patients from current opioid therapy to TRANSDUR-Sufentanil;
  • Evaluate the efficacy of TRANSDUR-Sufentanil administration; and
  • Evaluate the safety and tolerability (including local effects) of continuous TRANSDUR-Sufentanil administration at a dose delivering adequate pain control.

Design

The TRANSDUR-Sufentanil Phase IIb clinical trial was an open label, two-stage study to explore the titration (conversion) schedule for transitioning opioid-experienced patients with non-malignant moderate to severe chronic pain from current oral (e.g., OxyContin(R)) and transdermal opioid (e.g., Duragesic(R)) therapies to TRANSDUR-Sufentanil. After screening and recording of baseline (before TRANSDUR-Sufentanil therapy) measurements with respect to average pain intensity and other matters, patients were randomized into multiple titration regimens. After achieving an endpoint of adequate, stable pain control and an acceptable safety profile on TRANSDUR-Sufentanil, patients entered a 28-day continuous treatment maintenance period, followed by a 7-day follow-up period to ensure that an adequate pain control regimen was re-established. In this study conducted at 11 sites in the U.S., a total of 74 patients entered screening, of which 36 entered the maintenance period.

Results

Dose Titration Interval

In this st
'/>"/>