Trevena Sees Path Forward for Rejected Opioid Pain Medicine

Shares of Trevena soared nearly 120 percent in Monday trading after the company announced it has found a path forward for its intravenous opioid-pain reliever oliceridine.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to the company in November, one month after an advisory committee rejected the drug. When the FDA issued the CRL, the regulatory agency requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing. The FDA also requested certain additional nonclinical data and validation reports, Trevena said in November.

However, on Monday, Pennsylvania-based Trevena said that following a Type A meeting with the FDA, the agency provided hope for a path forward. On Monday, Trevena said it will submit a detailed protocol and analysis plan to the FDA soon and, following feedback, will initiate the required study in the first half of 2019. The FDA agreed that the company’s current safety database will support labeling at a maximum daily dose of 27 mg. Trevena also noted that the FDA requested that the company conduct a study in healthy volunteers to collect the requested QT interval data. The study should include placebo- and positive-control arms, the FDA said. Additional efficacy data was not required. The FDA did request supporting nonclinical data related to the characterization of the 9662 metabolite and the remaining product validation reports when the oliceridine NDA is resubmitted, the company said.

Carrie L. Bourdow, president and chief executive officer of Trevena, said the company is encouraged by the meeting results from the FDA and believes this is a path forward for regulatory approval.

“We remain committed to our mission of ensuring access to safe and effective treatment options for hospital patients who require an IV opioid to manage their moderate to severe acute pain,” Bourdow said in a statement.

Trevena has had issues getting oliceridine across the finish line. Not only did the FDA reject it in 2018, but the company also had issues with the drug following a late-stage analysis in 2017. Following a Phase III study, analysts questioned whether or not the drug could distinguish itself from morphine, particularly in some measures of safety. That resulted in a shakeup at the company that saw about 30 percent of the staff laid off in order to provide funds to support the continued development of the opioid treatment.

While the company does have a path forward to potentially see approval of oliceridine, Trevena is the subject of a class action lawsuit. The lawsuit was filed by investor-rights law firm Bernstein Liebhard in October after the FDA advisory committee rejected oliceridine. According to the lawsuit, Trevena executives, led by recently retired Trevena CEO Maxine Gowen, misled shareholders regarding an April 2016 end-of-phase meeting with the FDA. The lawsuit suggests that the company painted a rosy picture regarding the meeting with the FDA as the company planned to take oliceridine into Phase III trials.

https://www.biospace.com/article/trevena-sees-path-forward-for-rejected-opioid-pain-medicine/