Pacira Pharmaceuticals (PCRX) announced positive top line Phase III results for EXPAREL as a single-dose femoral nerve block in the adductor canal for post-surgical regional analgesia in patients undergoing total knee arthroplasty, notes John McCamant, biotech expert and editor The Medical Technology Stock Letter.
EXPAREL achieved the study’s primary endpoint demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (p<0.01).
EXPAREL also achieved a statistically significant reduction in post-surgical opioid consumption through 96 hours (p<0.01) compared with bupivacaine HCl, a key secondary endpoint. EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl.
Total knee arthroplasty is a significant market opportunity and the positive Phase III data increases the odds for a premium acquisition of the company.
For its next steps, PCRX will submit a supplemental an sNDA to the FDA early next year seeking expansion of the EXPAREL label to include femoral nerve block in the adductor canal. The company will also submit the full results from the Phase III trial for presentation at future scientific conferences and for publication in a peer-reviewed journal.
PCRX continues to execute and expand EXPAREL use by proving it is a highly effective drug that reduces both pain and significantly reduces opioid use in a broad range of surgical procedures.
In our view, we continue to believe it is only a matter of when for the company to be acquired at a large premium as a bolt-on for an established company. The stock is a buy under $80 with a target price of $100.
