榴莲视频

Pacira BioSciences has against the American Society of Anesthesiologists (ASA) -- and a dozen editors and authors of its official medical journal -- claiming that a trio of articles published in Anesthesiology created the incorrect impression that the company's drug bupivacaine liposome (Exparel) is not an effective analgesic.

The Parsippany, New Jersey-based biotech is seeking retractions of what it says are false and misleading statements made about Exparel in the of Anesthesiology, as well as unspecified damages, . Retraction Watch was first to report that Pacira had .

Exparel is a non-opioid pain medication used to prolong post-surgery pain relief, and is approved by the FDA for both adult and pediatric patients. Pacira alleged in its complaint that the Anesthesiology articles in question reflect a bias against Exparel among the journal's editorial staff.

According to the complaint, the ASA published articles that were scientifically unsound and that failed to disclose that certain authors were accepting payments from competing pharmaceutical or drug device manufacturers. Pacira further claimed that one of Anesthesiology's editors has been a longstanding proponent of opioid-based treatments.

Exparel is used as a local anesthetic administered at the time of surgery to control pain and reduce or eliminate the use of opioids afterwards, according to Pacira. The company said the way the drug works is by encapsulating bupivacaine in liposomal chambers and releasing it into the body over a prolonged period of time as chamber walls break down. It's designed to work for longer periods of time than non-liposomal bupivacaine, and as a result, patients may need fewer doses of other pain medications, according to the company.

Exparel was first approved by the FDA in 2011. It was given the green light for a second indication in 2018, and for use in children earlier this year.

Pacira claimed in its complaint that its business relationships and revenues are being harmed by the Anesthesiology articles, titled, "Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia: A Systematic Review and Meta-analysis." The company further stated that its competitors are capitalizing on the articles' false claims to promote their own products, and that other medical journals are now referencing the articles and distributing them to even wider audiences.

The conclusions of the articles, "create the false impression that Exparel -- a drug approved by the FDA and used by over eight million patients over the past nine years -- is not an effective pain medication," the complaint stated. "As a result, Pacira has suffered and will continue to suffer significant pecuniary harm as both existing and potential customers who have seen the disparaging articles, have either canceled contracts for Exparel, declined to purchase Exparel, or are considering removing Exparel from hospital formularies."

In a statement provided to 榴莲视频 in an email, Pacira's CEO and Chairman Dave Stack said the company's policy is not to comment on pending litigation.

The company noted in its complaint that sales of Exparel represented about 96% of its total revenues in 2019 and 2020. Pacira, a publicly traded company, reported total revenues of about $430 million last year, up 2% from $421 million the year prior.

In 2015, that the company's drug pricing of Exparel had come under scrutiny. In prior litigation, Pacira sued the FDA over certain restrictions on marketing practices.

Theresa Hill, director of public relations for the ASA, told 榴莲视频 in an email that the organization believes the current case is "without merit," but that it "cannot comment further on pending litigation."

Comment