After FDA Advisory Committee Rejection, Trevena Now Faces a Class Action Lawsuit

Published: Oct 12, 2018 By

Man in suit banging gavel and pointing thumbs down

Things seem to have gone from bad to worse for Pennsylvania-based Trevena, Inc. This week the company saw a U.S. Food and Drug Administration (FDA) advisory committee reject its intravenous pain treatment, and now a class action lawsuit filed against the company claims Trevena executives have misled investors for years.

As could be expected, investors have shown their displeasure by dumping company stock. Shares of Trevena have plunged as a result. In premarket trading this morning, shares of Trevena have fallen to 7 cents from Thursday’s close of 95 cents.

On Thursday, Chesterbrook, Penn.-based Trevena announced that an FDA advisory committee voted eight to seven against the approval of oliceridine for the management of moderate to severe acute pain in adult patients for whom an intravenous (IV) opioid, such as morphine, is warranted. The FDA had set a PDUFA date of Nov. 2 for potential approval of the therapy. The regulatory organization can still approve Trevena’s treatment. It is not bound by the advisory committee’s recommendation, but typically follows the advice of the committee.

The FDA accepted Trevena’s New Drug Application in January following positive results from three separate Phase III studies.

This isn’t the first time that Trevena has had issues with oliceridine, which would be marketed under the name Olinvo. Last October the company laid off 30 percent of its research and development staff as part of an effort to save money to support the development and hoped-for approval of Olinvo. That decision came after some concerns were raised over the drug following a Phase III report. Analysts questioned whether or not the drug could distinguish itself from morphine, particularly in some measures of safety.

Despite the FDA Advisory panel’s rejection, Trevena said it will continue to work closely with the FDA as the PDUFA date nears.

“We continue to believe that the totality of evidence presented and discussed today supports the utility of oliceridine as a new analgesic option for the management of moderate to severe acute pain for patients in hospitals or other controlled clinical settings,” Carrie L. Bourdow, president and chief executive officer, said in a statement.

While the company is aiming to persevere, its troubles are far from over. Investor rights law firm Bernstein Liebhard announced Thursday that it had filed a securities class action lawsuit on behalf of investors who acquired Trevena stock between May 2, 2016 and Oct. 8, 2018. 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.

Citing released minutes from the meeting between Trevena and the FDA, Bernstein Liebhard said the company was not as forthcoming in its public statements as the minutes showed. The lawsuit said that the FDA did not agree with proposed dosing of oliceridine in the Phase III trial, it did not agree with the proposed primary endpoint of the Phase III trial and did not agree with the proposed non-inferiority (NI) margin for comparing morphine to oliceridine – the same point that was noted above.

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