Pacira Pharmaceuticals, Inc. PCRX announced that it has completed an End-of-Review process with the FDA regarding its supplemental New Drug Application (sNDA) on lead drug Exparel.
Exparel is a liposome injection of bupivacaine indicated for single-dose administration into the surgical site to produce post-surgical analgesia. Pacira was seeking to expand Exparel’s label to include nerve block to provide postsurgical analgesia.
However, Pacira received a complete response letter in Mar 2015 from the FDA following the review of the sNDA. Consequently, the company scheduled an End-of-Review meeting with the Division of Anesthesia, Analgesia and Addiction Products ("DAAP") of the Center for Drug Evaluation and Research to discuss the contents of the letter.
The meeting was held in Apr 2015, and was attended by members of the executive team and regulatory advisors for Pacira.
As per FDA guidance, Exparel could be used for a broad spectrum of nerve blocks instead of remaining limited to one narrow indication. Hence, Pacira plans to conduct additional phase III studies for upper and lower extremity nerve blocks in order to cover majority of nerve blocks performed in the U.S.
Thus, Pacira expects to work with the FDA, finalize the design of the phase III trials and initiate studies by the end of 2015.
We note that Exparel is Pacira’s only approved product, making the company solely dependent on it for growth. A label expansion of the drug would further boost its sales.
Additionally, Pacira requested a type C meeting in Mar 2015 to discuss the DepoFoam spray manufacturing process for Exparel. On a positive note, Pacira received feedback from the FDA DAAP, whereby the agency proposed to demonstrate comparability and provide adequate data in support of the spray process. The approach seemed acceptable to the company.
Pacira currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Actelion Ltd. ALIOF, Gilead Sciences Inc. GILD and Valeant Pharmaceuticals International, Inc. VRX. All three sport a Zacks Rank #1 (Strong Buy).
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