- Pacira Pharmaceuticals (NASDAQ:PCRX) is down 7% premarket on robust volume in response to its announcement of results from two Phase 3 clinical trials evaluating EXPAREL (bupivacaine liposome injectable suspension) for prolonged regional pain relief.
- The first study assessed EXPAREL as a brachial plexus block in patients undergoing upper extremity surgery (total shoulder arthroplasty or rotator cuff repair). It met the primary endpoint of a statistically valid effect on pain scores over 48 hours as measured by area under the curve (p<0.0001). It also met key secondary endpoints of reducing total postsurgical opioid consumption through 48 hours (p<0.0001), opioid-free subjects through 48 hours (p<0.01) and time to first opioid rescue through 48 hours (p<0.0001).
- The second study assessed EXPAREL as a femoral nerve block in patients undergoing lower extremity surgery (total knee arthroplasty or TKA). It failed to demonstrate a statistically significant effect on pain (p>0.05) due to a significant deviation from the study protocol at a single center. The company says if this site is excluded, the study met the primary endpoint.
- The company received a CRL from the FDA in 2015 in response to its original marketing application filed in 2014. The agency requested an additional clinical trial to establish the efficacy of EXPAREL in a setting beyond femoral nerve block for TKA and a study following safety outcomes through the time to reach the maximum concentration of EXPAREL.
- The company believes it has enough data for a submission of a supplemental New Drug Application seeking approval to expand EXPAREL's label to include administration via nerve block to produce regional analgesia.
- Complete results will be submitted for presentation at future scientific conferences and for publication.
- Previously: Pacira gets Complete Response Letter instead of approval for Exparel expanded label (March 2, 2015)
- Now read: AbbVie's Long Shot At Proving Rova-T Doubters Wrong
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