Taking the Proactive Path to Approval – The Strategic Advantage of Early Messaging in FDA Submissions

Challenge

Pacira BioSciences, Inc. (Pacira), a specialty pharmaceutical company, planned to submit a supplemental New Drug Application (sNDA) to expand the indication for EXPAREL®, a long-acting local anesthetic, to include two additional nerve blocks. To support the submission, Pacira conducted three Phase 3 clinical trials.

To meet internal milestones, the sNDA had to be submitted within 12 weeks of completing the last of these studies. The Pacira team faced the challenge of writing clinical study reports (CSRs) for two of the trials while concurrently preparing the sNDA.

Approach

Pacira engaged 3D Communications to support the development of the sNDA. 3D’s medical writers and Science Lead brought significant therapeutic expertise and helped shape the submission strategy. The team worked proactively to develop key messaging, outline the clinical and integrated summaries, and draft the sNDA in anticipation of favorable results for the new studies, which helped the medical writers hit the ground running once results became available.

Result

The sNDA was submitted on schedule. The two new Phase 3 studies were positive and met their primary endpoints, so there were few changes to the messaging prepared in advance. 3D medical writers worked in close coordination with Pacira’s internal team to author the clinical summary documents while CSRs were being finalized in parallel. The FDA had few substantive questions, and the agency approved the expanded indications without convening an Advisory Committee meeting (ADCOM).

Impact

Proactive planning and the right partner can streamline regulatory submissions and help avoid downstream challenges—including an ADCOM. 3D Communications brings deep expertise in scientific communications and medical writing to help sponsor teams prepare clear, compelling clinical narratives that drive successful regulatory submissions.