Tiny Trevena returns to FDA in second bid for controversial opioid painkiller
A year and a half after being rebuffed, microcap biotech Trevena is heading back to the FDA in a second bid to win approval for its opioid painkiller.
Trevena pitched their drug, known as oliceridine, as an opioid that used different signaling pathways in the brain and would come with fewer side effects than traditional compounds, such as morphine. But when the FDA reviewed the drug in 2018, they came to different conclusions, saying it had “an abuse potential, overdose potential and ability to produce physical dependence that is similar to other mu-opioid agonists.”
After an advisory committee voted 8-7 against approval, the FDA issued a CRL. The company went back to the clinic, at the agency’s request, to run a test on QT prolongation, a measure of heart function. The study is designed to elucidate the drug’s potential to cause these kinds of arrhythmias, which are one of the most common and dangerous side effects of opioids.
Now Trevena has refiled their NDA. They said they anticipate a 6-month review process because the application is considered a class 2 response to the agency’s action letter. A PDUFA date is set for August 7.
Oliceridine, tentatively branded as Olinvo, is administered intravenously and would be indicated for moderate-to-severe pain for patients in hospitals. It would be dosed at a maximum of 27 mg, a significant reduction from the 100 mg maximum dose the company once proposed.
Any opioid drug approval could stoke criticism, though. Last year, after the agency approved AcelRx’s new opioid Dsuvia, an anesthesiologist on the agency’s outside advisory committee accused the FDA of “willful blindness that borders on the criminal.”
That criticism could be aggravated by the questions that still swirl about Trevena’s past conduct. Attorneys at Bernstein Liebhard accused Trevena execs, specifically ex-CEO Maxine Gowen, of misleading investors when she announced, in 2016, that the company was “very pleased” with a meeting with the FDA and had come to a general agreement on the design of a Phase III trial. But the 2018 FDA review revealed the agency in fact had deep qualms about the trial design.
Still, the advisory committee voted in favor of that AcelRx drug and experts caution that the common phrase “opioid epidemic” is best characterized as the “opioid abuse epidemic.” Many patients, including those with cancer or other illnesses that cause significant chronic pain, still need these drugs to maintain a decent quality of life.