Pacira Pharmaceuticals ($PCRX) has gained its first big FDA green light for a drug since wrapping a small IPO in February. U.S. regulators approved the company's long-acting bupivacaine product, Exparel, for treating pain after surgeries, the company said this morning.
The company's stock was up just shy of 2% as of 12:30 pm ET today, after the price had surged considerably and then settled down in pre-market trading this morning.
The FDA approval of the Parsippany, NJ-based developer's drug came after a series of successful clinical trials, including a pivotal study in which it was used to treat pain in patients who underwent surgeries to remove hemorrhoids. That study showed that the one dose of the long-acting drug, which is injected at the surgical site, provided significant drops in pain and opioid use for up to 72 hours after the surgeries.
Typically, the product's active ingredient alone, bupivacaine, lasts only about 7 hours when injected after surgeries and then clinicians have to turn to opioids and other remedies to control post-surgical pain, according to the company.
"Traditional opioid medications, while effective at providing pain relief, have a long list of unwanted side effects," Dr. Sonia Ramamoorthy, associate professor of surgery at the University of California, San Diego, said in Pacira's release. "Exparel, a single dose administration, non-opioid therapy, has the potential to reduce or delay the use of opioids following inpatient and outpatient surgical procedures."
With expected sales of Exparel, Pacira can now bank on revenue from a third marketed product and deliver a key victory to investors who supported the firm's initial public offering back in February. While the difficulty of the market for public debuts in biotech forced the company to significantly reduce its IPO price from a desired $14 to $16 per share down to $7 per share, now those backers who had faith in the company will be rewarded. Exparel is expected to be the No. 1 product for Pacira, which also gets revenue from two marketed products that use its drug-delivery technology. Still, new drug launches have been difficult as of late and are not always home runs for developers.
"This FDA approval is an important milestone for Pacira, as well as the millions of patients undergoing surgical procedures in the U.S. each year," Dave Stack, the company's CEO, said in a statement. "We are excited to launch Exparel in the United States."
- here's this morning's release