Pacira's ($PCRX) hopes of expanding the use of its surgical pain drug took a hit this week, as the FDA rejected its application to get Exparel approved through a new delivery pathway.
The drug, combining bupivacaine with a proprietary drug delivery technology called DepoFoam, is already approved for injection into tissues at the site of surgery. Pacira's latest filing sought to get it cleared for so-called nerve block procedures, in which analgesics are injected close to a nerve to provide widespread numbing after a procedure.
But the FDA was apparently unconvinced by the application, handing the company a complete response letter and sending Pacira's shares down nearly 20% in the process.
The company didn't disclose what led to the rejection but said it would "immediately" schedule a meeting with the FDA's analgesics department to go over what it needs to do to eventually win approval.
|Pacira CEO David Stack|
"We are reviewing the contents of the CRL and will work actively with the FDA to bring this important new indication to our core and growing business in infiltration," CEO Dave Stack said in a statement.
As Reuters notes, Exparel accounted for nearly 100% of Pacira's $197.6 million in 2014 revenue. And, in annual results released last week, the company said it expects 2015 sales to reach as high as $330 million, with 10% of that figure coming from its previously expected expansion of Exparel's indication.
- read the announcement
- here's the Reuters story