Pacira BioSciences Faces Generic Competition as Two Companies File Abbreviated New Drug Applications for EXPAREL
核心洞察
Pacira BioSciences (搜索) has been notified of Abbreviated New Drug Application filings from The WhiteOak (搜索) and Qilu (搜索) for generic versions of EXPAREL, its flagship postsurgical pain management drug.
EXPAREL is the first and only multivesicular liposome local anesthetic approved for postsurgical local analgesia in patients aged 6 years and older and regional analgesia via specific nerve blocks in adults.
The drug utilizes multivesicular liposome technology to deliver bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption.
Pacira BioSciences (搜索) has received notifications of Abbreviated New Drug Application (ANDA) filings from two companies seeking to develop generic versions of EXPAREL, the company's flagship postsurgical pain management drug. The WhiteOak (搜索) and Qilu (搜索) have both submitted applications to the FDA for generic versions of the bupivacaine liposome injectable suspension.
EXPAREL's Clinical Profile and Market Position
EXPAREL is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older, and postsurgical regional analgesia via an interscalene brachial plexus block in adults, a sciatic nerve block in the popliteal fossa in adults, and an adductor canal block in adults. The safety and effectiveness of EXPAREL have not been established to produce postsurgical regional analgesia via other nerve blocks besides these specifically approved applications.
The product combines bupivacaine with multivesicular liposomes, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting.
Clinical Efficacy and Opioid Reduction
By utilizing the multivesicular liposome platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption, though the clinical benefit of the opioid reduction was not demonstrated in studies.
Safety Profile and Administration Guidelines
In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In pediatric studies, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat.
EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement, with duration depending on where and how much of EXPAREL was injected and may last for up to 5 days. The drug is not recommended for patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women.
Broader Portfolio Impact
The generic competition for EXPAREL comes as Pacira continues to focus on the commercialization of its broader portfolio, which includes ZILRETTA and iovera (搜索). The company has outlined plans to expand the use of these products to additional indications and opportunities, with ongoing clinical trials for EXPAREL, ZILRETTA, iovera and other product candidates, including PCRX-201.
Pacira's strategy includes evaluating, developing and pursuing additional product candidates utilizing its proprietary multivesicular liposome (pMVL) drug delivery technology, as well as seeking approval for commercialization of its products in other jurisdictions through European Medicines Agency Marketing Authorization Applications.