Pacira Pharmaceuticals Inc (NASDAQ:PCRX) announced new data regarding the benefit of EXPAREL®(bupivacaine liposome injectable suspension) for patients undergoing third molar (wisdom teeth) extraction, marking the official launch of the product to the oral surgeon community. EXPAREL is a local analgesic that provides prolonged non-opioid postsurgical pain control.
As the nation battles the opioid addiction crisis, there is a particular opportunity to offer opioid alternatives to treat postsurgical pain in oral surgery patients. A recent study published in the Journal of the American Medical Association (JAMA) found an exceedingly high percentage of patients between 14 and 24 years of age are prescribed opioids for surgical tooth extractions;1 for many patients, this may be their first exposure to opioids. According to a government report, the highest rates of opioid abuse are seen among 18 to 25 year olds.2
“We are pleased to work with the oral surgery community to help make EXPAREL available to patients undergoing third molar extraction and other relevant oral and maxillofacial procedures where long-lasting pain control is required to help patients get through the immediate postsurgical period,” said Dave Stack, Chief Executive Officer and Chairman of Pacira. “We believe the ability to offer patients and their caregivers—often their parents, in the case of third molar extraction patients—a safe and effective non-opioid option will not only help reduce overreliance on opioids, but also mitigate exposure to their unwanted side effects and the potential for long-term safety risks like opioid misuse, abuse, or addiction.”
The formal launch of EXPAREL to the oral surgeon community coincides with the presentation of new data on the safety and efficacy of the product in this patient population, which is occurring this week at the annual meeting of the American Association of Oral and Maxillofacial Surgeons (AAOMS) in Las Vegas, Nevada.
The data were generated from a prospective, randomized, double-blind, placebo-controlled study during which patients having all four wisdom teeth removed were randomized to receive a lidocaine nerve block followed by infiltration with either EXPAREL 133 mg (10 mL; 59 subjects) or placebo (10 mL saline; 30 subjects). A total of 166 subjects were enrolled in the study; 77 subjects were excluded due to protocol deviations.
Patients receiving EXPAREL demonstrated a numerically lower overall mean opioid consumption compared to patients administered placebo. Other key findings included:
- Significantly lower pain scores at 48 hours (P=0.0226), the primary endpoint of the study. Pain scores were also significantly lower compared to placebo at 24 hours (P=0.0192), 72 hours (P=0.0469), and 96 hours (P=0.0450).
- No difference in adverse event rates between the EXPAREL and placebo groups were observed; treatment-emergent adverse events were mild or moderate.
“This preliminary study data provides encouraging support for both the strong safety profile of EXPAREL and its potential to deliver prolonged pain management following oral surgery,” said Stuart Lieblich, DMD, a study investigator and lead author on the AAOMS presentation. “When considering oral surgery procedures, especially third molar extraction, postsurgical pain often ranks among patients’ top concerns so the ability to ease anxiety and offer a non-opioid option that provides ample pain management during the first few days after surgery—when pain is often at its worst—is a real benefit to both clinicians and our patients, alike.” (Original Source)
Shares of Pacira are currently trading at $36.03, down $4.34 or -10.74%. PCRX has a 1-year high of $80.25 and a 1-year low of $31.08. The stock’s 50-day moving average is $41.65 and its 200-day moving average is $45.42.
On the ratings front, Pacira has been the subject of a number of recent research reports. In a report released today, Wedbush analyst Liana Moussatos reiterated a Buy rating on PCRX, with a price target of $109, which represents a potential upside of 179.5% from where the stock is currently trading. Separately, on the same day, Mizuho’s Irina Rivkind Koffler reiterated a Buy rating on the stock and has a price target of $64.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Liana Moussatos and Irina Rivkind Koffler have a total average return of 11.4% and 22.1% respectively. Moussatos has a success rate of 40% and is ranked #228 out of 4172 analysts, while Koffler has a success rate of 57% and is ranked #29.
The street is mostly Bullish on PCRX stock. Out of 8 analysts who cover the stock, 5 suggest a Buy rating , 2 suggest a Hold and one recommends to Sell the stock. The 12-month average price target assigned to the stock is $69.67, which represents a potential upside of 78.6% from where the stock is currently trading.
Pacira Pharmaceuticals, Inc. is a specialty pharmaceutical company. It develops, commercializes, and manufactures pharmaceutical products for use in hospitals and ambulatory surgery centers. It develops pharmaceutical products based on its proprietary DepoFoam drug delivery technology. The company markets EXPAREL, a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia; and DepoCyt(e), a liposomal formulation of the chemotherapeutic agent cytarabine indicated for the intrathecal treatment of lymphomatous meningitis, a cancer of the immune system. Its product pipeline comprise EXPAREL that has completed Phase II clinical trials for postsurgical analgesia-nerve block administration; DepoNSAID, which is in preclinical trials for the relief of that is in preclinical trials acute pain; and DepoTXA is currently in pre-clinical development, which is used to treat or prevent excessive blood loss during surgery by promoting hemostasis.