Pacira Pharmaceuticals Inc. (NASDAQ: PCRX) was leading the bulls in Tuesday’s session on positive news from the U.S. Food and Drug Administration (FDA). The company announced that it achieved an amicable resolution with the FDA for a lawsuit filed earlier this year. Effectively, this resolution lifts the restriction on Exparel.
Originally, Exparel was approved in 2011 for numbing pain post-surgery. However in 2014, the FDA issued a letter that the drug was only approved for certain types of surgeries, such as bunion or hemorrhoid surgeries — a smaller indication than Pacira was marketing the drug as.
Exparel, it is currently indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. Exparel represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting.
After the court’s findings, Exparel is now approved for multiple indications in the postsurgical setting.
Dave Stack, CEO and chairman of Pacira, said:
We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate. This is especially important given the burgeoning U.S. opioid epidemic, underscored by the reality that one in 15 patients will go on to long-term use after receiving an opioid in the hospital setting.
Shares of Pacira were trading up 15.5% at $72.11 on Tuesday, with a consensus analyst price target $79.40 and a 52-week trading range of $35.78 to $121.95.
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