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Pacira (PCRX) Up on Data From Exparel Label Expansion Study
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Pacira BioSciences, Inc. (PCRX - Free Report) has announced positive top-line data from a phase III study evaluating its marketed drug, Exparel, as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty.
The double-blind, active-controlled phase III study evaluated the safety, efficacy and pharmacokinetics of Exparel admixed with bupivacaine HCl versus bupivacaine HCl for the given indication.
Data from the study showed that treatment with Exparel led to a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl, the study’s primary endpoint.
Treatment with Exparel also led to a statistically significant reduction in postsurgical opioid consumption through 96 hours versus bupivacaine HCl, a key secondary endpoint of the study. Exparel was generally well tolerated with a safety profile similar to that of bupivacaine HCl.
Pacira plans to submit a supplemental new drug application (sNDA) to the FDA seeking label expansion of Exparel to include femoral nerve block in the adductor canal in early 2023.
Shares of Pacira were up 5.3% on Wednesday following the announcement of the news. The stock has lost 10.4% this year compared with the industry’s decline of 25.2%.
Image Source: Zacks Investment Research
Pacira’s flagship product, Exparel, a liposome injection of bupivacaine, is indicated as a single-dose administration into the surgical site to produce postsurgical analgesia for patients in the United States.
In March 2021, the FDA approved Pacira’s supplemental new drug application seeking approval of Exparel for use in children aged six years and above.
Exparel has witnessed a strong uptake since its launch and has been a key revenue driver for Pacira. The drug generated sales worth $266.2 million in the first half of 2022, reflecting an increase of 8.8% year over year.
The majority of Pacira’s top line is driven by Exparel sales. A successful label expansion of the drug into additional indications is likely to boost sales further in the days ahead.
Ayala Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 17.5% for 2023 in the past 60 days.
Earnings of Ayala Pharmaceuticals have surpassed estimates in each of the trailing four quarters. AYLA delivered an earnings surprise of 9.91%, on average.
Assertio’s earnings per share estimates have increased 27.5% for 2022 and 13.8% for 2023 in the past 60 days.
Earnings of Assertio surpassed estimates in three of the trailing four quarters and missed on the other occasion. ASRT delivered an earnings surprise of 126.39%, on average.
Fusion Pharmaceuticals’ loss per share estimates narrowed 8.5% for 2022 and 14.8% for 2023 in the past 60 days.
Earnings of Fusion Pharmaceuticals surpassed estimates in each of the trailing four quarters. FUSN delivered an earnings surprise of 16.22%, on average.
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Pacira (PCRX) Up on Data From Exparel Label Expansion Study
Pacira BioSciences, Inc. (PCRX - Free Report) has announced positive top-line data from a phase III study evaluating its marketed drug, Exparel, as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty.
The double-blind, active-controlled phase III study evaluated the safety, efficacy and pharmacokinetics of Exparel admixed with bupivacaine HCl versus bupivacaine HCl for the given indication.
Data from the study showed that treatment with Exparel led to a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl, the study’s primary endpoint.
Treatment with Exparel also led to a statistically significant reduction in postsurgical opioid consumption through 96 hours versus bupivacaine HCl, a key secondary endpoint of the study. Exparel was generally well tolerated with a safety profile similar to that of bupivacaine HCl.
Pacira plans to submit a supplemental new drug application (sNDA) to the FDA seeking label expansion of Exparel to include femoral nerve block in the adductor canal in early 2023.
Shares of Pacira were up 5.3% on Wednesday following the announcement of the news. The stock has lost 10.4% this year compared with the industry’s decline of 25.2%.
Image Source: Zacks Investment Research
Pacira’s flagship product, Exparel, a liposome injection of bupivacaine, is indicated as a single-dose administration into the surgical site to produce postsurgical analgesia for patients in the United States.
In March 2021, the FDA approved Pacira’s supplemental new drug application seeking approval of Exparel for use in children aged six years and above.
Exparel has witnessed a strong uptake since its launch and has been a key revenue driver for Pacira. The drug generated sales worth $266.2 million in the first half of 2022, reflecting an increase of 8.8% year over year.
The majority of Pacira’s top line is driven by Exparel sales. A successful label expansion of the drug into additional indications is likely to boost sales further in the days ahead.
Zacks Rank & Stocks to Consider
Pacira currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector are Ayala Pharmaceuticals, Inc. , Assertio Holdings, Inc. (ASRT - Free Report) and Fusion Pharmaceuticals Inc. (FUSN - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Ayala Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 17.5% for 2023 in the past 60 days.
Earnings of Ayala Pharmaceuticals have surpassed estimates in each of the trailing four quarters. AYLA delivered an earnings surprise of 9.91%, on average.
Assertio’s earnings per share estimates have increased 27.5% for 2022 and 13.8% for 2023 in the past 60 days.
Earnings of Assertio surpassed estimates in three of the trailing four quarters and missed on the other occasion. ASRT delivered an earnings surprise of 126.39%, on average.
Fusion Pharmaceuticals’ loss per share estimates narrowed 8.5% for 2022 and 14.8% for 2023 in the past 60 days.
Earnings of Fusion Pharmaceuticals surpassed estimates in each of the trailing four quarters. FUSN delivered an earnings surprise of 16.22%, on average.