Chesterbrook-based Trevena has refiled its drug application to the Food and Drug Administration for IV oliceridine, an opioid pain relief medicine with fewer side effects than traditional opioids, writes John George for the Philadelphia Business Journal.
In late 2018, the FDA rejected the biopharmaceutical company’s application for oliceridine, with the proposed brand name Olinvo, as a treatment for moderate to severe pain in hospitalized patients.
At the request of the FDA, Trevena conducted further testing of its lead drug candidate last year and set a goal of resubmitting the application in the first quarter of this year.
The company expects a six-month review period for its application.
In the original review, FDA staff raised potential safety concerns about the drug candidate’s “abuse potential, overdose potential, and ability to produce physical dependence that is similar to other (opioids).”
Trevena said its medicine uses a different pathway to provide relief from pain, which was specifically developed to still provide the opioid’s pain-reducing potential but with fewer adverse effects.
According to Trevena CEO Carrie Bourdow, the oliceridine resubmission is “a significant milestone for the program and an important achievement for the company.”
Read more about Trevena in the Philadelphia Business Journal here.