Trevena Inc (NASDAQ:TRVN) plans to submit the latest painkiller, named as oliceridine, for publicizing nod with the U.S. FDA in the fourth quarter. A novel, intravenous opioid advanced offered pain relief to people coming out of surgery as against standard morphine but with lesser side effects like vomiting, depressed breathing and nausea. However, the report from 2 late-stage clinical studies released may not be notable enough to delight shareholders.
The biotech stock has failed to post any gains this week. Trevena plans to file the aforementioned painkiller oliceridine for marketing nod with the U.S. FDA in the fourth quarter. The filing necessitates additional safety data from a clinical study not yet completed.
The U.S. FDA previously gave oliceridine Breakthrough Therapy Designation for its prospect to become a safer and better tolerated intravenous anesthetic for postoperative patients with acute pain. However, this update was not taken positively by the market, and the biotech stock recorded a decline. The market has anticipated that the company will release the study data.
Oliceridine functions by binding to opioid receptors, similar to fentanyl or morphine. However, oliceridine is intended to be more selective, escaping a share of the opioid receptor that results in depressed breathing and gastrointestinal side effects. Opioid-linked side effects in this group of post-surgical patients are hardly life threatening, however can add costs and days to hospitalization stays.
Trevena reported that in the two Phase 3 trials, oliceridine at 3 dose levels was equated to morphine and placebo in people following tummy-tuck and bunion surgery. Oliceridine recorded the primary endpoints of both trials with statistically better rate of pain relief as against placebo.
On the major secondary endpoints of the trials, the high and middle doses of oliceridine showed painkilling efficacy versus morphine. All 3 doses of oliceridine demonstrated lower rates of depressed breathing as against morphine, however merely the lowest, least effective dose was statistically substantial.