Pacira Pharmaceuticals Inc (NASDAQ: PCRX) stock fell to a 3 1/2 month low as the stock plunged 16.11% (source: Google finance) as the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC)  did not reach a unanimous decision on EXPAREL (bupivacaine liposome injectable suspension) as a nerve block to produce regional analgesia. Only 4 of the 10 members had voted to recommend approval while six believed that more research is needed to further support the proposed new indication. Further, the committee’s feedback will be considered by the FDA in its review of the company’s sNDA seeking expansion of the EXPAREL label. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is April 6th, 2018.

Moreover, despite the number of studies submitted by PCRX in the application, most of the committee believed there was not enough data provided, due in part to small patient numbers and a high amount of opioid use. The suggestions were made by some committee members that future studies should include a comparator arm instead of the use of placebo, specifically when it comes to stating whether bupivacaine liposomal injectable suspension is opiate-sparring.

Additionally, there was concern that bupivacaine liposomal injectable suspension is already in use for the indication sought by PCRX, despite its unapproved status.

Meanwhile, the sNDA filing is based on the positive data from a Phase 3 study of EXPAREL in femoral nerve block for total knee arthroplasty (lower extremity) and a Phase 3 study of EXPAREL in brachial plexus block for shoulder surgeries (upper extremity). It also includes the data from eight company-sponsored studies with safety and pharmacokinetic data through 120 hours. In addition, the sNDA includes the data from two investigator-initiated studies that provide additional experience in smaller, peripheral nerve block settings. EXPAREL is currently indicated for infiltration into the surgical site to produce postsurgical analgesia and has been used in over 3.5 million patients across the United States.

Furthermore, the Analgesic Drug Products Advisory Committee (AADPAC) reviews and evaluates the available data related to the safety and effectiveness of marketed and investigational human drug products for use in anesthesiology and surgery and makes appropriate recommendations to the Commissioner of Food and Drugs.

According to tipranks.com, 13 analysts have covered the stock while recommending a “Moderate Buy”. PCRX has an average price target of $48, which is a further upside of 58.15%.