Pacira BioSciences, Inc. PCRX announced that the phase IV CHOICE study on its lead drug Exparel in patients undergoing Cesarean section (C-section) achieved its primary endpoint with a statistically significant reduction in total postsurgical opioid consumption through 72 hours (P≤0.001).
The study also achieved the key secondary endpoint with Exparel demonstrating statistical significance for reduction in the incidence and severity of itching through 72 hours following surgery.
Per the company, 169 patients undergoing elective C-section in the study were randomized to receive either 150 mcg morphine spinal anesthesia + standard of care postoperative pain regimen, 50 mcg morphine spinal anesthesia plus Exparel transversus abdominis plane (TAP) field block or an opioid-free spinal anesthesia + Exparel TAP block.
Notably, in the EXPAREL arms, patients were administered with a protocol-defined postoperative pain management regimen comprising ketorolac, acetaminophen and ibuprofen. Importantly, the Exparel TAP block demonstrated superiority over morphine spinal-based standard of care.
Shares of Pacira have rallied 11.3% in the past year compared with the industry’s rise of 0.3%.
We remind investors that in January 2019, Pacira announced that its phase IV study on Exparel, which evaluated patients undergoing Cesarean section (C-section), met the primary endpoint with a statistically significant decrease in total postsurgical opioid consumption throughout 72 hours.
The CHOICE study is a follow-up on this study, which is designed to evaluate a completely opioid-free arm with Exparel including opioid-free spinal anesthesia.
Exparel is a liposome injection of bupivacaine, indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
Exparel revenues grew 23% year over year during the first nine months of 2019. Continued adoption of the drug for TAP and infiltration procedures for abdominal plus genitourinary surgeries should boost its sales going forward. The company is currently looking for partners to expand the medicine’s geographical footprint.
In June 2019, the European Medicines Agency accepted the marketing authorization application for Exparel to treat postsurgical analgesia. An opinion from the Committee for Medicinal Products for Human Use is expected in the second half of 2020.
Notably, Pacira has partnership with Johnson & Johnson JNJ wherein the latter continues to support the uptake of Exparel through its world class educational programs and orthopedic procedural solutions for the former.
Zacks Rank & Stocks to Consider
Pacira currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Dermira, Inc. DERM and Verrica Pharmaceuticals Inc. VRCA, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Dermira’s loss per share estimates have narrowed 1.2% for 2020 over the past 60 days. The stock has skyrocketed 108.3% in the past year.
Verrica Pharmaceuticals’ loss per share estimates have narrowed 4.4% for 2020 over the past 60 days. The stock has jumped 26.7% in the past year.
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