Sentences with word «oliceridine»

Those are definitely fair arguments that could play a huge role if oliceridine doesn't clearly differentiate itself from morphine in both of these trials — and underscore why investors may want to keep any position on the small side for the time being.
So while it's probably unwise to back up the truck with this speculative biotech stock, I do think it's worth owning a small position in case oliceridine hits pay dirt next year.
Now, the first thing to understand about oliceridine's ongoing studies is that the primary endpoint for both trials is the drug's ability to outperform placebo as a pain reliever — a feat it has performed in spades in its mid-stage trials that even led to a breakthrough therapy designation from the FDA last February.
Having said that, there is a compelling bear case surrounding oliceridine's ultimate commercial potential that shouldn't be taken lightly.
If oliceridine produces a favorable clinical profile relative to the gold standard, morphine, it could end up generating hundreds of millions in sales.
In phase III trials in postsurgical patients reported in February, oliceridine proved to be as effective a painkiller as morphine, and quicker to act.
Trevena, a firm based in Chesterbrook, Pennsylvania, announced on 2 November that it has submitted oliceridine, an intravenous opioid meant for use in hospitalized patients, to FDA for marketing approval.
And in a paper out this week in Cell, a veteran opioid researcher and her colleagues unveil new biased opioid agonists that could surpass oliceridine, though they haven't been tested in people yet.
The pharmaceutical company Trevena, headquartered in King of Prussia, Pa., has been working its way through the U.S. Food and Drug Administration's drug approval process with a molecule called oliceridine.
In that trial, oliceridine provided at least as much pain relief as morphine did, and patients who received the new drug suffered significantly less nausea, vomiting and hypoventilation (a measure of slowed breathing) than patients on morphine.
One possible application for oliceridine is as an alternative to opioids such as morphine or fentanyl for treating hospitalized patients who have acute pain after surgery or from cancer or a condition such as kidney stones.
The short story is that oliceridine is an injected drug indicated for the treatment of moderate to severe pain in a post-surgical setting.
Pain relievers, after all, either work or they don't, and all the evidence so far clearly suggests that oliceridine is indeed an effective pain reliever.
So I'm willing to go out on a limb here and say that oliceridine will most likely hit the mark in each trial in terms of its primary endpoint.
In short, bears have suggested that oliceridine's target market is only a small fraction of the broader acute - pain space, and Trevena may be unable to convince payers to provide coverage for what will almost certainly be a far more expensive drug than morphine.
George Budwell (Trevena): The clinical - stage biotech Trevena is set to release top - line results from two phase 3 studies (APOLLO - 1 and APOLLO - 2) for its lead drug candidate, oliceridine, in the first quarter of 2017.
But oliceridine's value proposition actually depends on how well it stacks up against morphine from both a safety and efficacy standpoint, which is the secondary endpoint in each trial.
Biotech company Trevana's drug, oliceridine, acts as a μ - opioid receptor to activate a pain - relieving signaling pathway with less triggering of a separate path that leads to depressed breathing.
In studies reported in April in San Francisco at the Annual Regional Anesthesiology and Acute Pain Medicine Meeting, oliceridine was as effective as morphine in patients recovering from bunion removal and others who had tummy tuck surgeries.
Just like Trevena's oliceridine, the new molecule does not activate beta - arrestin 2.
In an earlier round of testing, 200 people who had undergone abdominoplasty — a tummy - tuck surgery that entails a foot - long incision — were randomly assigned to receive the new drug — oliceridine — or morphine or a placebo following surgery.
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