Pacira Pharmaceuticals, Inc. (PCRX - Free Report) submitted a Prior Approval Supplement (PAS) with the U.S. Food and Drug Administration (FDA) for an additional manufacturing site for Exparel.
Assuming that the FDA accepts the PAS for review, Prescription Drug User Fee Act (PDUFA) action date is expected in early Apr 2014.
Pacira’s pain management drug Exparel is currently approved by the FDA for administration into the surgical site to produce postsurgical analgesia. The drug was approved by the FDA in the final quarter of 2011 and launched in Apr 2012.
Exparel generated $25.1 million of revenues in the first year of launch. In the third quarter of 2013, net Exparel revenues were $20 million, up 31.6% sequentially. At the end of Sep 2013, Exparel had a customer base of 1,732. Pacira reported an average of 23 new customers per week in the reported quarter.
Exparel is evaluated in two phase III nerve block studies – one where it is studied as a femoral nerve block for patients undergoing total knee arthroplasty while the other study evaluated the safety and efficacy of Exparel in intercostal nerve block for posterolateral thoracotomy. The first part of femoral nerve block study showed positive results and the final part is in progress. The intercostal nerve block study did not achieve its primary endpoint. As per FDA a single study meeting its primary endpoint is sufficient to gain approval for the nerve block indication. Pacira plans submit supplemental New Drug Application in early 2014.
Enrolment for a phase IV study in lower abdominal soft tissue surgeries is in progress. The program will evaluate the timing of the procedure as well as the dose and volume of Exparel, while measuring the opioid-sparing opportunity. Data from the study is expected by the end of 2013 or early 2014.
Pacira carries a Zacks Rank #4 (Sell). Some better-ranked stocks include Aeterna Zentaris Inc. (AEZS - Free Report) , Actelion Ltd. and Jazz Pharmaceuticals plc (JAZZ - Free Report) , each carrying a Zacks Rank #1 (Strong Buy).