Decision due for Pacira’s postoperative non-opioid pain drug Print E-mail
By Brian Wilson   
Thursday, 27 October 2011 06:13
FDA calendarPacira Pharmaceuticals Inc. (NASDAQ:PCRX) is a company that focused on the efficacy of current medications, and is developing products that utilize their proprietary Depofoam® technology to better control the release of drugs into the body.  It’s FDA-approved product DepoCyt(e)® is one example. This is a sustained-release liposomal formulation of the drug cytarabine, which is used for the treatment of myphomatous meningitis (a deadly cancer of the immune system).

PCRX Pipeline View

EXPAREL is Pacira’s big take on improving postoperative pain treatment. The drug is a bupivacaine injection (a local analgesic commonly used in postsurgical care for patients), but the difference is that the bupivacaine is encapsulated in DepoFoam. This has shown to be effective in prolonging the painkilling effects of this analgesic by up to ten times or more.

Pacira is hoping to meet an unmet demand for non-opioid post-surgical analgesics. EXPAREL will deliver an extremely long-lasting dose of bupivacaine; which should not only reduce the amount of discomfort patients suffer shortly after surgical procedures, but will reduce the time that patients spend on opioid medications as well.

A look at the BioMedReports FDA Calendar shows that Pacirca filed its NDA for EXPAREL in September 2010, which was officially accepted at the end of that year. Under PDUFA guidelines, the FDA is expected to have a complete review of EXPAREL on October 28, 2011 which should be a big catalyst for the stock since EXPAREL is the flagship product of Pacira.

Prior to some presentations earlier in October, Dave Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. said: "We look forward to sharing new comparative data highlighting the pain control advantages that EXPAREL offers, as well as pharmacokinetic data, with the pharmacy and anesthesiology communities, who we believe will find great utility in EXPAREL should it be approved later this year."

EXPAREL is designed to extend the duration of analgesia provided by the commonly used local analgesic, bupivacaine. Based on clinical trial data, EXPAREL provides continuous and extended postsurgical analgesia for up to 72 hours*, compared with bupivacaine’s analgesic timeline of 7 hours or less**. Pacira believes EXPAREL will address a significant unmet medical need for a long-acting non-opioid postsurgical analgesic. Pacira believes that the utilization of EXPAREL in the armamentarium of post operative analgesics may reduce the dependence on opioid use in the post operative setting and delay the time to first opioid use so that oral rather than parenteral opioids can be used. This may:
  • Result in improved patient satisfaction and outcomes;
  • Minimize breakthrough episodes of pain and significantly reduce the consumption of supplemental opioid medications and;
  • Simplify postsurgical pain management and reduce hospital cost and staff time on non-patient care, monitoring of infusion pumps, catheters, leading to improved hospital economics
A look at the stock chart shows the stock is looking to break past a level of key resistance at the $10.98 level with some support at the $10.27 level.





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