(Reuters) - Trevena Inc on Tuesday said only some doses of its experimental opioid painkiller were found as effective as morphine in two late-stage studies, even though the drug outperformed a placebo - meeting its main study goals.
Trevena’s intravenous formulation, which is designed to extract the pain-reducing potential of an opioid but with fewer side-effects, was tested in patients following a bunion or tummy-tuck surgery.
Three doses of the drug were tested against a placebo and morphine in the two trials. While oliceridine outperformed the placebo in terms of achieving pain relief - meeting the main goals of each trial - only two doses were found to be as effective as morphine.
Shares of the King of Prussia, Pennsylvania-based company slumped 35.4 percent to $4.60 in premarket trading. Up to Friday’s close, the stock had risen 21 percent this year.
The abuse of opioids — a class of drugs that include heroin and prescription painkillers — has assumed epidemic proportions in the United States. An overdose can cause euphoric highs and even disrupt parts of the brain that control breathing.
While oliceridine was found to have induced lower rates of depressed breathing as well as vomiting and nausea compared to morphine, only some doses achieved a statistically significant impact.
The company intends to submit a marketing application for the product in the fourth quarter, pending the outcome of a third study that is still ongoing.
Oliceridine, which if approved will be sold as Olinvo, has already secured the U.S. Food and Drug Administration’s breakthrough therapy status.
Reporting by Natalie Grover in Bengaluru; Editing by Shounak Dasgupta and Maju Samuel