Pacira Pharmaceuticals, Inc.’s (PCRX) shares lost almost 11% immediately after the receipt of a warning letter from the FDA’s Office of Prescription Drug Promotion (OPDP) regarding certain promotional materials on Exparel. However, shares gained 3.6% in the subsequent trading session. Overall, shares are down 7.8% since the announcement.
Late last week, Pacira announced that it has received a warning letter from the OPDP accusing the company of making misleading statements related to Exparel in educational technique flashcards (administration guides) and a journal advertisement submitted under Form FDA-2253.
Exparel is approved in the U.S. for single-dose infiltration into the surgical site to produce postsurgical analgesia in patients aged 18 years or above.
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 alleged that the administration guides describe administration techniques for Exparel in laparoscopic cholecystectomy and open cholectomy, while the dosage and administration section of the approved product label recommends the usage of Exparel only in cases of bunionectomy and hemorrhoidectomy. The approved label also mentions that Exparel has not been clinically proved to be safe and effective in any other procedure.
Other promotional materials submitted by Pacira under Form-2253 claims Exparel’s safety and efficacy in various surgical procedures including knee arthoplasty and open hysterectomy among others.
Moreover, the journal advertisement wrongly portrayed that Exparel can control pain for up to 72 hours. However, the approved product label states that in clinical studies Exparel showed significant reduction in pain intensity for up to 24 hours, beyond which there was minimal or no difference between Exparel and placebo in terms of reducing mean pain intensity suffered by the patients. Hence, the OPDP concluded that the claim made by the journal advertisement regarding Exparel’s efficacy was overstated and misleading.
The OPDP claimed that according to the Federal Food, Drug and Cosmetic (FD&C) Act, Pacira’s activities misbranded Exparel and were distribution violative. The OPDP requested the company to take immediate actions to stop the violation of the FD&C Act. Pacira has to submit a written response by Oct 6 to the OPDP and a list of all misleading promotional materials, along with a detailed plan regarding the discontinuation of such promotion of Exparel.
Pacira said that it will work with the FDA for the resolution of these issues.
Pacira currently holds a Zacks Rank #2 (Buy). Some well-placed stocks in the pharmaceutical sector are Endo International plc (ENDP), Lannett Company, Inc. (LCI) and Mallinckrodt plc (MNK). All these stocks 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
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment