October 12, 2017
By Alex Keown, BioSpace.com Breaking News Staff
CHESTERBROOK, Pa. – Trevena, Inc. is banking its future on possible approval of troubled pain medication Olinvo eight months after Phase III data raised some questions over the drug’s safety profile.
This morning, the company said it was halting investments in early-stage research and slashing its R&D team by 30 percent to focus on approval of Olinvo. Trevena Chief Executive Officer Maxine Gowen said the decision to focus company resources on the potential approval of Olinvo was made after a “thorough review” of its portfolio. The move, which includes the job cuts, is expected to save Trevena $40 million over the next three years.
As part of its new strategy, Trevena will cut 21 employees at the company, including Michael Lark, the company’s chief scientific officer. He will remain with the company through December then leave, Trevena said in its announcement. Gowen said in a statement that the new strategy made the jobs cuts necessary.
“I would like to extend my sincere gratitude to the talented and dedicated individuals affected by this plan for their many contributions to the organization. I would also like to thank Michael for his tremendous leadership of our R&D activities since he joined Trevena at its founding. Finally, I want to thank our remaining employees for their continued commitment to our long-term success as we move forward to the approval and commercial launch of Olinvo,” Gowen said in a statement. Investors have not responded well to the new strategy. Shares of Trevena, Inc. plunged in after-hours trading to a low of $1.79. The stock closed at $2.37 on Wednesday.
Although the company reported in February that its pain treatment, oliceridine (Olinvo), which has been thought to be a replacement for morphine, met its Phase III endpoints, however, there was some concern over secondary endpoints. Those secondary endpoints did not differentiate Olinvo from morphine. In March, analyst George Budwell wrote in The Motley Fool that he does not see many hospitals acquiring a drug that’s more expensive than morphine and doesn’t have a superior clinical profile. In his analysis of the Phase III data, Budwell said Olinvo was unable to outperform morphine on key safety measures like respiratory burden and nausea at higher doses. Because of that, he said the data lowered its appeal as a “safer, more tolerable alternative to morphine.”
Despite that, Trevena anticipates filing a New Drug Application with the U.S. Food and Drug Administration later this month, the company said in its announcement.
While Trevena said it was suspending its early stage research, the company said it intends to complete the ongoing Phase I trial of TRV250 for acute migraine. Data from that trial is expected later this year. When the Phase I data is analyzed, the company said it will assess options for further development of the drug, as well as a series of novel S1P modulators for neuropathic pain.
When Trevena issues its next quarterly report on Sept. 30, the company said it expects to report cash, cash equivalents and marketable securities of approximately $76.7 million. Trevena said that amount should be sufficient to support operations into the fourth quarter of 2018.
