Pacira Pharmaceuticals, Inc.(PCRX) recently announced positive data from a phase IV study, EXCLAIM, evaluating the use of Exparel for postsurgical analgesia in patients undergoing four common plastic surgery procedures, namely, abdominoplasty, breast augmentation, breast reduction or a combination of abdominoplasty/breast procedure. The study revealed low pain scores, high satisfaction with pain control, minimal opioid use and excellent overall benefit of analgesia (OBAS).
Under the EXCLAIM study (n=49), patients gave ratings to their pain intensity; reported the number of opioids taken as rescue medication and took note of any adverse effect associated with the use of opioids.
Exparel is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. Exparel is the first and only multivesicular liposome local anesthetic that can be used in the same manner as local anesthetics in the peri- or postsurgical setting.
Exparel gained US Food and Drug Administration (FDA) approval in Oct 2011 and was launched in Apr 2012. In the fourth quarter of 2012, Exparel revenues were $7.8 million. Pacira has completed a phase II study with Exparel in postsurgical analgesia – nerve block.
Two nerve block studies are currently being conducted (intercostal block study in posterolateral thoracotomy patients and a femoral nerve block in total knee arthroplasty (TKA) patients) – these studies are scheduled to finish this year. Positive results would allow the company to submit a Supplemental New Drug Application (sNDA) in 2014.
Other candidates in Pacira’s pipeline are DepoNSAID for infiltration and intraarticular indication and DepoMethotrexate for rheumatoid arthritis and oncology.
Pacira carries a Zacks Rank #4 (Sell). Currently, companies like Lannett Company, Inc. (LCI), UCB (UCBJF) and QLT Inc. (QLTI) look more attractive in the pharmaspace with a Zacks Rank #1 (Strong Buy).
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