Exparel Liposomal Bupivacaine Approved in the EU
Pacira BioSciences, Inc., the leading global provider of non-opioid pain management options announced that the European Commission has granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults.
Exparel is a non-opioid analgesic that provides proven, long-lasting postsurgical pain control with decreased opioid consumption when used as part of a multimodal pain management regimen. Multimodal therapy uses a combination of non-opioid pain medications before, during, and after surgery to effectively control postsurgical pain while helping patients remain alert and comfortable during their recovery. Multimodal therapy is advocated by leading health care organizations such as the American Pain Society, the American Society of Anesthesiologists, the American Dental Association, the American College of Surgeons, and the Centers for Disease Control and Prevention.
“We are pleased to see news of the European Commission’s approval of EXPAREL and look forward to the opportunity to bring a safe and effective opioid alternative to surgical patients across Europe,” said Dave Stack, Chief Executive Officer and Chairman of Pacira BioSciences. “Europe has long been at the forefront of enhanced recovery after surgery – or ERAS – models of care. With the European Commission’s broad approval for EXPAREL across a wide variety of surgical settings and administration techniques, we see a well-defined position for EXPAREL to play an integral role in further optimizing postsurgical protocols and accelerating postoperative recovery.”
Why is Exparel liposomal authorised in the EU?
The European Medicines Agency decided that Exparel liposomal’s benefits are greater than its risks and it can be authorised for use in the EU. Studies had shown that Exparel liposomal was effective at managing pain after different surgical procedures. The safety profile was considered acceptable.
An overview of Exparel liposomal and why it is authorised in the EU Exparel liposomal is a local anaesthetic that is used in adults to treat pain after certain operations. It can be used either for local pain relief by injecting it around the edges of small to medium sized surgical wounds or for regional pain relief by injecting it around the nerves that supply the lower limbs or the shoulder. It contains the active substance bupivacaine.
How is Exparel liposomal used?
Exparel liposomal is injected either around the edges of small to medium sized surgical wounds or around the nerve supplying the operation site in the leg or shoulder area. The dose depends on the size of the operation site and the area that needs to be numbed, and the patient’s physical condition.
Exparel liposomal should be given in a setting where trained personnel and appropriate resuscitation equipment are available to promptly treat patients in case they develop side effects of the heart and nervous system. The medicine can only be obtained with a prescription.
How does Exparel liposomal work?
The active substance in Exparel liposomal, bupivacaine, is an anaesthetic that temporarily numbs the area to which it has been applied by blocking pain signals to the brain. Bupivacaine has been available since the 1960s. In Exparel liposomal, it is enclosed in ‘liposomes’ (tiny fat particles) which release bupivacaine slowly.
What benefits of Exparel liposomal have been shown in studies?
Four studies in 703 patients have shown that Exparel liposomal is effective at reducing pain scores when used for local pain relief around small to medium sized surgical wound sites and for regional pain relief in the surgery of the knee and around the shoulders
What are the risks associated with Exparel liposomal?
The most common side effects with Exparel liposomal (which may affect more than 1 in 20 people) are dysgeusia (taste disturbances) and oral hypoaesthesia (reduced sensation in the mouth). The most important serious side effects are convulsions (fits), serious dysrhythmia (irregular heartbeat), serious hypotension (low blood pressure) and cardiac arrest. Exparel liposomal must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a chemical structure related to the active ingredients (amide-type local anaesthetics). It must not be used as obstetrical paracervical block anaesthesia (local anaesthetic injected at the top of the vagina) and must not be given by injection into a blood vessel or into a joint. For the full list of restrictions, see the package leaflet.
What measures are being taken to ensure the safe and effective use of Exparel liposomal?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Exparel liposomal have been included in the summary of product usage and the package leaflet.
As for all medicines, data on the use of Exparel liposomal are continuously monitored. Side effects reported with Exparel liposomal are carefully evaluated and any necessary action taken to protect patients.