Pacira isn’t exactly in an enviable position – the company reported in April the receipt of a subpoena from the U.S. Department of Justice, and sales of Exparel in the first quarter of the year came in below analyst estimates. Exparel is a liposomal bupivicaine injection approved for use as a local, post-surgical analgesic. In March the FDA rejected the company’s application to expand Exparel’s use into nerve block to provide postsurgical analgesia.
On Thursday, Pacira completely removed previous guidance for Exparel revenues of $310 – $330 million in 2015, with 10% of projected revenues coming from the nerve block indication.
The DoJ subpoena relates to Pacira’s marketing and promotional practices for EXPAREL. In February the company resolved a separate Warning Letter from the U.S. FDA’s Office of Prescription Drug Promotion (OPDP). It seems the FDA took issue with how Pacira characterizedsthe longevity of Exparel’s pain-blocking capabilities in its sales activities. In clinical studies, Exparel demonstrated a significant reduction in pain intensity scores compared to placebo for up to 24 hours. There was no difference in pain intensity between EXPAREL and placebo from 24 to 72 hours, though there was a cumulative decrease in opioid consumption through the 3-day endpoint.