The U.S. Food and Drug Administration (FDA) approved EXPAREL (bupivacaine liposome injectable suspension) on October 20, 2011 [1]. The New Drug Application (NDA) number associated with this approval is 022496 [1].
What is EXPAREL used for?
EXPAREL is indicated for the treatment of postoperative pain, which means it is used to manage pain after surgery [1]. It is administered by healthcare professionals [1].
How does EXPAREL work?
EXPAREL is a non-opioid local anesthetic that works by temporarily blocking nerve signals in the body [2]. This blockage reduces the sensation of pain [2]. It utilizes multivesicular liposome technology, which allows for the extended release of the anesthetic [3]. This sustained release mechanism is designed to provide pain relief over a longer duration compared to conventional local anesthetics [3].
When does EXPAREL's patent protection expire?
Information regarding the specific patent expiry dates for EXPAREL is available through resources like DrugPatentWatch.com [4]. Patent landscapes can be complex, with multiple patents covering different aspects of a drug, including its formulation, method of use, and manufacturing [4].
What are the alternatives to EXPAREL for pain management?
Alternatives to EXPAREL for postoperative pain management include opioid analgesics, non-opioid analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), and other local anesthetic techniques [2]. The choice of pain management strategy depends on the type and severity of pain, patient factors, and the specific surgical procedure [2].
Who manufactures EXPAREL?
EXPAREL is manufactured by Pacira BioSciences, Inc. [5].
What clinical data supports EXPAREL's use?
Clinical trials have evaluated EXPAREL's efficacy and safety in various surgical settings. Studies have demonstrated its ability to reduce the need for opioid pain medication in the postoperative period [2]. For example, in studies for bunionectomy and general surgery, EXPAREL provided significant pain relief compared to placebo and reduced opioid consumption [2].
What are the risks associated with EXPAREL?
Common side effects of EXPAREL include nausea, constipation, headache, and vomiting [1]. Like other local anesthetics, EXPAREL can cause temporary loss of feeling and muscle movement where it is injected [1]. Serious side effects can occur if the anesthetic spreads into the body, potentially affecting the brain and heart [1]. It is crucial that EXPAREL is not injected into a blood vessel or nerve [1].
Can biosimilars be developed for EXPAREL?
As EXPAREL is a liposomal injectable suspension, its development involves complex manufacturing processes. The creation of biosimilars for complex biological products or complex drugs like EXPAREL can be challenging and is subject to specific regulatory pathways [6]. The patent status and exclusivity periods play a significant role in the potential for biosimilar or generic competition [4].
What are patient concerns regarding EXPAREL?
Patients may have concerns related to the side effects of EXPAREL, the duration of pain relief, and the potential need for rescue pain medication if EXPAREL is insufficient [2]. Understanding that EXPAREL is a non-opioid option may also be a point of interest for patients seeking to avoid opioid use [2].
How is EXPAREL administered?
EXPAREL is administered by a healthcare professional directly into the surgical site during surgery [1]. It is not intended for intravenous injection [1].
What is the cost of EXPAREL?
The cost of EXPAREL can vary based on geographic location, healthcare provider, and insurance coverage [7]. As a branded pharmaceutical product with advanced delivery technology, it is generally priced higher than generic pain relief options [7].
How does EXPAREL compare to other local anesthetics?
Unlike traditional local anesthetics that provide short-term pain relief, EXPAREL's liposome encapsulation allows for a sustained release of bupivacaine over an extended period, typically up to 72 hours [3]. This prolonged action can reduce the need for repeated dosing or rescue analgesia [3].
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**Cited Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022496s000ltr.pdf
[2] https://www.exparel.com/
[3] https://www.pacira.com/products-pipeline/exparel/
[4] https://drugpatentwatch.com/
[5] https://www.pacira.com/
[6] https://www.fda.gov/vaccines-blood-biologics/biosimilars/what-biosimilar-interchangeable-biosimilar
[7] https://www.goodrx.com/exparel