A novel, intravenous opioid developed by Trevena (TRVN) - Get Trevena, Inc. Report provided pain relief to patients coming out of surgery comparable to standard morphine but with fewer side effects like nausea, vomiting and depressed breathing. However, the results from two late-stage clinical trials reported Tuesday may not be good enough to please investors.
Trevena intends to submit the new painkiller, known as oliceridine, for marketing approval with the U.S. Food and Drug Administration in the fourth quarter, the company said. The FDA filing requires additional safety data from a third clinical trial not yet completed.
The FDA previously granted oliceridine with Breakthrough Therapy Designation for its potential to become a better tolerated and safer intravenous painkiller for postoperative patients suffering from moderate-to-severe acute pain.
Trevena shares fell 19% to $5.76 in Tuesday's pre-market trading following the announcement of the oliceridine phase III studies. At Friday's $7.13 close, Trevena shares were up 21% for the year as investors anticipated the release of the data.
Oliceridine works by binding to opioid receptors in the brain, similar to morphine or fentanyl. However, oliceridine is designed to be more selective, avoiding a portion of the opioid receptor that causes gastrointestinal side effects and depressed breathing.
Opioid-related side effects in post-surgical patients are rarely life threatening but can add days and costs to hospitalization stays.
In the two phase III studies, oliceridine at three dose levels was compared to placebo and morphine in patients following bunion and tummy-tuck surgery. Oliceridine achieved the primary endpoints of both studies with statistically superior rate of pain relief compared to placebo.
On the key secondary endpoints of the studies, the middle and high doses of oliceridine demonstrated painkilling efficacy comparable to morphine.
All three doses of oliceridine showed lower rates of depressed breathing compared to morphine but only the lowest, least efficacious dose was statistically significant.
Likewise, oliceridine caused less vomiting and nausea compared to morphine but the improved tolerability was not statistically significant at all dose levels.
Trevena withheld specific numbers in Tuesday's announcement so the data could be presented at a future medical meeting. Oliceridine, if approved, will carry a significantly higher price tag over generic morphine, so to be used by hospitals, Trevena will need to make a convincing case that oliceridine's better tolerability and safety is a net cost saver.
"We believe the data for all three dose regimens will support FDA approval of IV oliceridine with a broad indication of management of moderate-to-severe acute pain," said Trevena CEO Maxine Gowen, in a statement.
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