The small biopharma company Trevena (TRVN) suffered a setback Thursday after a panel of outside experts convened by the Food and Drug Administration recommended against the approval of its intravenous painkiller. The 7-8 vote means the FDA is almost guaranteed to reject the painkiller, called oliceridine, at or near its review decision deadline of Nov. 2.
But Trevena may have other equally serious problems to deal with in the near future. Earlier this week, investors were told that Trevena’s management, led by CEO Maxine Gowen, misled them for years about the company’s dealings with the FDA.
About the Author Reprints
Over the past two years I have communicated with Dr. Violin regarding efforts toward PDFUA approval of Oliceridine. When I read the briefing materials, I was very surprised at the negative information present. My understanding is that a good working relationship existed. In watching the advisory committee meeting, much positive information did come out about this impressive drug. Speakers composed of trial patients, nurses and doctors pleaded for this drug to be approved because it was so very, very effective. I was surprised it was not approved. Did the drug meet efficacy, safety, abusive standards and the answers were all yes. I believe Trevena is diligently working their tails off too determine what they can do to get this very effective drug approved. I suspect an approval would be along the lines of mid dosage levels approved while high level doses are not until another trial confirms the safety levels of high dosing. I am not associated with Trevena but I do hold stock in the company. As to the lawsuits, I do believe greater transparency is needed. Let us hope that Trevena follows through here and gets approval to hold off these lawsuits; yes the company should have been more honest in their dealings with the FDA – however I’m not ready to throw the entire company to the curve because of this. Because they do have a great new drug that can benefit patients, doctors and even the pharma industry as a whole in demonstrating such biotechnology works.
“The 7-8 vote means the FDA is almost guaranteed to reject the painkiller, called oliceridine, at or near its review decision deadline of Nov. 2.”
There is a 15% chance — statistically, but far greater in my estimation — that this gets FDA approval in November. That is how often FDA accepts a drug with the advisory still voting no against it. What’s more, that figure factors in drugs that are given a firm no. TRVN’s drug received a 7-8 vote, with the majority of the no’s being on the fence. Many of the no voters were quoted as being torn between yes and no, clearly a good sign for TRVN if they can clean up some of the addressed issues before the November vote.
Seems to me like you’re also trying to steer people in the wrong direction, Adam. We should be buying this stock right now based on the 100+ pg report and also based on what happened today. At this price, this is a home run.
If their IV opiod is not FDA approved in november, it’s virtually guaranteed it will be next year. Sign me up for those odds, at this price…
There is a 15% chance — statistically, but far greater in my estimation — that this gets FDA approval in November
Vinny, I agree with you.
If a company misleads investors, maybe it’s time for some prison time. Enough with these bullshit lawsuits. Let’s start putting these CEO’s in jail.
James, I would offer that the FDA should follow through and provide rules and/or standards for companies to follow when reporting project status with the FDA. One suggestion is for FDA to provide public status of a project on their website for the public to view. This status would include a section for the company to make comments as well as the FDA. Drug approval has to be a partnership process, one party can not continue to function as a silent partner until the very end when approval is sought.