Shares of Pacira plunged more than 15 percent this morning after the company revealed the FDA panel’s decision.
Shares of Pacira Pharmaceuticals have plunged more than 15 percent this morning after the company revealed a U.S. Food and Drug Administration advisory panel recommended against approving expanded use of the company’s pain treatment Exparel.
In a six to four vote, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee questioned the efficacy and safety of Exparel, (bupivacaine liposome injectable suspension) as a nerve block to produce regional analgesia. The FDA is not bound by the committee’s recommendation, but it does carry a lot of weight when approval is on the line. The FDA is set to make its final consideration on April 6. The six who voted against the Pacira drug recommended the company conduct additional research to support the new indication, the company said this morning.
Exparel, a liposome injection of bupivacaine, is a single-dose local anesthetic injected into a surgical site as a post-surgical pain treatment. The drug provides targeted, non-opioid pain control by working right at the site of surgery, allowing for long-lasting pain relief. The drug has been approved for soft-tissue surgeries, orthopedic patients and for oral surgery. It was initially approved in 2011.
Pacira’s announcement did not provide full clarity of why the majority of the panel voted against the label expansion. Chief Executive Officer Dave Stack certainly disagreed with the outcome. In a statement this morning, he said the company is confident the data from its clinical program “provides all the necessary information to support expansion” of Exparel. Stack said the company will work with the FDA to address any questions as it looks to seek approval of the expanded label. He said it’s important to be able to offer long-lasting non-opioid pain control for patients.
In a note to clients, Janney analyst Ken Trbovich said he anticipates Pacira will have to “conduct studies in multiple anatomical sites to gain approval for use as a regional nerve block,” Investors Daily reported.
In an email to BioSpace, Canaccord Genuity pharma analyst Dewey Steadman said he anticipates the FDA issuing a Complete Response Letter to Pacira by the April 6 PDUFA date. He said it wasn’t entirely unexpected that the advisory panel voted against the label expansion “given recent investor sentiment and resounding negative commentary from FDA in panel docs released earlier this week.”
Pacira sought approval for Exparel based on Phase III study involving femoral nerve block for total knee arthroplasty, as well as a study of the use of Exparel in brachial plexus block for shoulder surgeries. In addition, the sNDA includes data from two investigator-initiated studies that provide additional experience in smaller, peripheral nerve block settings, Pacira said.
The FDA advisory panel’s vote against Pacira is the second stumble the company has experienced in the past year. Last summer, the company discontinued development of its DepoCyt product due to “persistent technical issues.” DepoCyt (cytarabine liposome injection) is a sustained-release liposomal formulation of the chemotherapeutic agent cytarabine. It was approved by the FDA in 2007 for the intrathecal treatment of lymphomatous meningitis, a life-threatening complication of lymphoma.
Shares of Pacira closed on Thursday at $36.10. As of 10:23 a.m. shares are trading at $30.12.
