Pacira BioSciences, Inc. PCRX announced that the FDA has approved its supplemental new drug application (sNDA) seeking approval of its long-acting local analgesic, Exparel, for use in children aged six years and above.
The sNDA was based on data from the phase III PLAY study, which evaluated Exparel infiltration in pediatric patients undergoing spinal or cardiac surgeries. Overall findings from the study were consistent with the pharmacokinetic and safety profiles for adult patients, with no safety concern observed. Per the FDA guidance, the primary objectives of the PLAY study were to evaluate the pharmacokinetics and safety of Exparel.
Notably the PLAY study evaluated the safety and pharmacokinetics of Exparel in patients aged 12 to less than 17 years, as well as in patients aged six to less than 12 years.
Shares of Pacira have rallied 17.4% so far this year compared with the industry’s increase of 2.3%.
We remind investors that Exparel is a liposome injection of bupivacaine, which is indicated for a single-dose administration into the surgical site to produce postsurgical analgesia for patients in the United States.
In November 2020, the European Commission granted marketing authorization to Exparel as a brachial plexus block or femoral nerve block for the treatment of post-operative pain in adults and as a field block for the treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults. The company expects to launch Exparel in Europe in the second half of 2021.
Exparel generated sales of $413.3 million in 2020, reflecting an increase of 1% year over year. The FDA’s nod for the pediatric patient population and the potential launch in Europe should drive sales of the drug in 2021.
Zacks Rank & Stocks to Consider
Pacira currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Can-Fite BioPharma Ltd. CANF, Ono Pharmaceutical Co., Ltd. OPHLF and Soleno Therapeutics, Inc. SLNO, 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.
Can-Fite BioPharma’s loss per share estimates have narrowed 21.7% for 2021 over the past 60 days. The stock has rallied 49.4% year to date.
Ono Pharmaceutical’s earnings estimates have been revised 10.4% upward for 2021 over the past 60 days. The stock has risen 2.4% year to date.
Soleno Therapeutics’ loss per share estimates have narrowed 26.3% for 2021 over the past 60 days.
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