Pacira Pharmaceuticals, Inc. PCRX announced that it has resolved its litigation with the FDA in relation with the promotional issues revolving around its lead drug Exparel.
As per the resolution, the FDA confirmed that Exparel has been approved for administration into the surgical site to produce postsurgical analgesia in a variety of surgeries that are not limited to those studied in its pivotal trials.
In addition, the FDA approved a labeling supplement for Exparel that will clarify and reinforce the indications for which Exparel was originally approved in 2011. As per this supplement, the use, efficacy and safety of Exparel is not limited to any specific surgery type or site, while its proper dosage and administration is based on various patient and procedure-specific factors.
Consequently, the warning letter issued to Pacira in Sep 2014 was withdrawn through a rescission letter.
We remind investors that in Sep 2014, the FDA Office of Prescription Drug Promotion (OPDP) issued a warning letter related to certain promotional materials. Consequently, Pacira had tried to address the issues.
In Sep 2015, Pacira filed a lawsuit against the FDA seeking a court ruling to defend its rights to promote Exparel for the approved indication. In April, Pacira had received a subpoena from the U.S. Department of Justice (DoJ), U.S. Attorney’s Office for the District of New Jersey relating to the company’s marketing and promotional practices for Exparel. The DoJ had asked the company to produce a broad range of documents related to the marketing and promotion of the drug.
Resolution of the matter should remove a major overhang from Pacira’s shares as Exparel is its prime product.
Pacira currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Corcept Therapeutics CORT, Mylan MYL, and Pluristem Therapeutics, Inc. PSTI. All three sport a Zacks Rank #1 (Strong Buy).
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