What: Trevena (NASDAQ:TRVN) is up more than 10% at 1:15 p.m. ET after the company announced that its pain medication oliceridine was given Breakthrough Therapy designation by the Food and Drug Administration.
So what: The designation allows Trevena more interaction with the FDA, which might help get its drug on the market quicker. More importantly, not every drug is granted Breakthrough Therapy designation, so the FDA's move is somewhat of an endorsement of the drug based on early clinical trial data.
That's no guarantee that the drug will gain FDA approval, but, for now, it is saying that oliceridine looks like the drug may provide a substantial improvement over the current therapies available for treating severe pain. Oliceridine's advantage appears to be on the safety side; a lower number of patients who took oliceridine had abnormally slow breathing, vomiting, and nausea compared to morphine in a phase 2 trial. Pain reduction was similar between oliceridine and morphine.
Now what: It's back to waiting for Trevena's investors. Last month, the company started a phase 3 trial, dubbed ATHENA-1, testing oliceridine in 900 patients to get more safety data for the drug. A phase 3 testing oliceridine's efficacy as the primary endpoint is scheduled to begin in the second quarter.
Until those clinical trials read out, investors won't know for sure whether oliceridine can get on the market, although based on the phase 2 data, investors -- and the FDA -- would certainly expect positive phase 3 data.