Pacira's Late-Stage Study On Exparel Label Expansion Positive

Pacira BioSciences Inc. (NASDAQ:PCRX) announced positive results from its phase III PLAY study of Exparel administered as a single-dose infiltration in pediatric patients undergoing spinal or cardiac surgeries. The study enrolled 98 patients to evaluate the pharmacokinetics and safety of the drug in two patient groups — aged 12 years to less than 17 years and 6 years to less than 12 years.

According to the guidance provided by the FDA, the primary objectives of the PLAY study were to evaluate the pharmacokinetics and safety of Exparel. The overall findings of the study were consistent with the pharmacokinetic and safety profiles for adult patients, with no safety concerns identified at a dose of 4 mg/kg. The full study results will be submitted for publication in the peer-reviewed medical literature later this year.

These results will provide the foundation for the company’s supplemental new drug application (sNDA) in the first half of 2020 seeking expansion of the Exparel label to include children aged six years or above. The pediatric program has been designed in consultation with FDA with a second phase III registration study of Exparel administered as a nerve block in the pediatric setting which is expected to start in 2020.

If approved, the drug will be the only local anesthetic approved for use in children.

However, the stock has gained 6.7% so far this year compared with the industry’s growth of 11.8%.

We would like to 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 in the United States. In April 2018, the FDA also approved the expansion of the Exparel label to include administration via nerve block for prolonged regional analgesia. With this nod, the drug became the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.

Notably, Pacira has a co-promotion agreement with DePuy Synthes, part of the Johnson & Johnson (NYSE:JNJ) family of companies, to market and promote the use of Exparel for orthopedic procedures in the U.S. market.

Zacks Rank & Stocks to Consider

Pacira is a Zacks Rank #3 (Hold) stock, currently.

A few better-ranked stocks in the medical drugs sector are Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) and Jounce Therapeutics Inc. (NASDAQ:JNCE) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ironwood’s earnings per share estimates have increased from 55 cents to 78 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 135.01%, on average.

Jounce Therapeutics’ earnings per share estimates have increased from $1.64 to $1.92 for 2019 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 27.10%, on average.

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