Pacira (PCRX) Reveals Additional Safety Data on Exparel
Pacira Pharmaceuticals, Inc. (PCRX) announced additional data from the analysis of data from six studies (phase I to phase III) on Exparel (bupivacaine liposome injectable suspension) for peripheral nerve blocks. The analysis showed that Exparel (doses of up to 266 mg) was similar to bupivacaine HCl as well as placebo in terms of safety.
Exparel is already approved in the U.S. for single-dose infiltration into the surgical site to produce postsurgical analgesia for up to 72 hours in patients aged 18 years or above.
Pacira said that Exparel’s safety profile in the peripheral nerve blocks studies is similar to that observed in patients who have undergone wound infiltration. This suggests that the safety success rate associated with Exparel for the treatment of peripheral nerve blocks will be similar to that observed for wound infiltration.
Additionally, results from the comparative analysis showed that patients on the Exparel arm, placebo arm and bupivacaine HCl arm experienced a similar rate of adverse events. Pacira maintained in its press release that these events appeared to be related to the procedure or opioid rescue rather than to the effect of Exparel itself.
Meanwhile, Pacira is working on expanding Exparel’s label. A supplemental new drug application (sNDA) for Exparel is currently under review in the U.S. for a nerve block indication. The FDA is expected to respond on the approval status for this indication by Mar 5, 2015.
Our Take
We are encouraged by the positive developments on Exparel. Exparel is one of the two marketed products at Pacira (the other one being DepoCyt(e)) and generated revenues of $79.3 million in the first half of 2014, up 209.1% year over year. Revenues from Exparel accounted for 94.6% of total revenues during this period.
Sales should be boosted with the product’s label expansion.
Pacira currently carries a Zacks Rank #1 (Strong Buy). Other well-placed stocks in the health care sector include Lannett Company, Inc. (LCI), Enanta Pharmaceuticals, Inc. (ENTA) and Actavis plc (ACT), carrying a Zacks Rank #1 (Strong Buy).
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