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Pacira's Exparel sNDA to be Reviewed by FDA Advisory Committee

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Shares of Pacira Pharmaceuticals, Inc. (PCRX - Free Report) declined about 6.6% on Nov 14. This followed the FDA’s notice stating that the company’s supplemental New Drug Application (sNDA) for  label expansion of Exparel (bupivacaine liposome injectable suspension) in the nerve block setting will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (“AADPAC”) before a final decision. 

Currently, Pacira intends to get the drug approved to include administration via nerve block for regional analgesia. The meeting related to the approval is scheduled to take place in mid-February next year. However, the action date set by the FDA remained unchanged on Apr 6, 2018.

Exparel is a liposome injection of bupivacaine, which is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.

So far this year, Pacira’s share price has increased 23.6%, as against the industry’s decline of 0.4%.

 

 

We remind investors that the company received a complete response letter (CRL) from the FDA in 2015, following a review of its sNDA for the use of Exparel in nerve block to provide postsurgical analgesia. The FDA requested another clinical trial to establish the efficacy of Exparel in an additional clinical setting beyond femoral nerve block for total knee arthroplasty (TKA).  Also, it requested a study following safety outcomes through the time to reach maximum concentration of Exparel.

However, the FDA accepted the company’s resubmission of its sNDA in October 2017. The sNDA filing was based on positive data from a phase III study of Exparel in femoral nerve block for total knee arthroplasty (lower extremity) and a phase III study of Exparel in brachial plexus block for shoulder surgeries (upper extremity). Notably, eight Pacira-sponsored studies support this expanded indication. The sNDA also includes data from two investigator-initiated studies that provide additional experience in smaller, peripheral nerve block settings.

A potential approval for the expanded indication of Exparel is expected to further boost sales of the company.

Zacks Rank & Stocks to Consider

Pacira carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space include Sucampo Pharmaceuticals, Inc. (SCMP - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Corcept Therapeutics Incorporated (CORT - Free Report) . While Sucampo sports a Zacks Rank #1 (Strong Buy),  Ligand  and Corcept carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings per share estimates have moved up from $1.01 to $1.11 for 2017 and from $1.06 to $1.21 for 2018 over the last 60 days. The company pulled off positive earnings surprises in three of the trailing four quarters, with an average beat of 15.63%.

Ligand’s earnings per share estimates have moved up from $3.68 to $3.70 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 8.22%. The share price of the company has increased 42.7% year to date.

Corcept’searnings per share estimates have moved up from 45 cents to 48 cents for 2017 and from 77 cents to 80 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters, with an average beat of 14.32%. The share price of the company has increased 150.7% year to date.

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