FDA advisers reject new use for Pacira nerve block
Pacira Pharmaceuticals’ bid to expand the use of its pain therapy Exparel has hit a major speed-bump after FDA advisers did not back an extended use as a nerve block after surgery.
While the vote of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee is not binding, the regulator usually follows the advice of its experts when making regulatory decisions.
The committee voted 6-4 against approval of Exparel (bupivacaine liposome injectable suspension), a new formulation of a well-established generic non-opioid painkiller which Pacira has proposed as a nerve block to produce regional analgesia.
There were ominous signs ahead of the meeting on Wednesday after the NASDAQ halted trading in the company’s common stock.
This was following a bad review from FDA staff, who were reviewing results of two new studies following a rejection in the new indication in 2015.
Exparel has been approved since 2011 to treat pain in patients having bunions or haemorrhoids removed, and Pacira hoped to expand its use after mixed study results, which showed the drug was effective as a nerve block in the thigh, but not between the ribs.
The company is also trying to get the wording of Exparel’s current indication changed to bring it in line with current clinical practice.
Pacira has submitted two new studies, involving a nerve blocks to help with knee and shoulder surgery, which are designed to address the FDA’s original concerns.
But the FDA staff reviewers still have concerns over some pharmacology results, and about the drug’s neurologic safety – although the new data provided by the manufacturer did no reveal any evidence of cardiac toxicity that had previously concerned regulators.
With a decision due on the new use in early April, there are now serious concerns that the FDA will reject Exparel’s extended use once again, even though the FDA is keen to find painkillers and analgesics that are not based around potentially addictive opioids.
Dave Stack, chairman and chief executive officer at Pacira Pharmaceuticals, said: “We look forward to working with the FDA to address any outstanding questions as we move through the sNDA review process towards our ultimate goal of offering additional flexibility in the way Exparel can be administered so that clinicians and patients alike have increased opportunity to realise the benefits of long-lasting non-opioid pain control.”
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