Pacira Pharmaceuticals Inc. (PCRX) announced that it has resolved its issue with the FDA related to the promotional aspects of its lead product Exparel.
We note that Pacira had received a warning letter from the FDA’s Office of Prescription Drug Promotion (OPDP) regarding certain promotional materials on Exparel. The letter from the agency had accused the company of making misleading statements related to Exparel in educational technique flashcards (administration guides) and a journal advertisement submitted under Form FDA-2253.
According to the OPDP, the administration guides show that Exparel is intended for indications for which it has not been approved. Additionally, the product label does not provide adequate directions for use in these indications.
The OPDP claimed that according to the Federal Food, Drug and Cosmetic (FD&C) Act, Pacira’s activities misbranded Exparel and violated the approved rules. The OPDP therefore requested the company to take immediate actions to stop violation of the FD&C Act.
As per the resolution, Pacira will now accurately communicate to its customers that Exparel is indicated for administration into the surgical site to produce postsurgical analgesia. The approval was based on pivotal trials conducted in excisional hemorrhoidectomy and bunionectomy surgical models. Hence, the basis of assessment of safety and efficacy has been limited to these two procedures.
Moreover, Exparel demonstrated a significant reduction in pain intensity scores compared to placebo for up to 24 hours in both the trials in the context of duration of efficacy.
The resolution of the matter with OPDP will remove a major overhang on Pacira’s shares as Exparel is its lead product.
Pacira currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Lannett Company, Inc (LCI), Biodel Inc. (BIOD) and Sucampo Pharmaceuticals (SCMP). All three carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment