- An advisory panel to the Food and Drug Administration narrowly voted against recommending approval of Trevena's intravenous opioid oliceridine, with eight committee members voting "no" against seven who voted in favor.
- While the FDA isn't required to follow the suggestions of its panels, the negative vote makes an approval of oliceridine for the management of moderate to severe acute pain in hospitals more uncertain. Trevena's application was based on data from three Phase 3 studies.
- Trevena stock slumped by more than 65% in value ahead of the meeting after the FDA released documents which raised key questions about the drug's efficacy and Trevena's trial design. Shares are now trading at about 85 cents apiece.
The FDA is set to decide on approval of oliceridine by Nov. 2 and, after this negative vote, the drug's prospects look considerably dimmer.
Newly appointed Trevena CEO Carrie Bourdow made an effort to put a hopeful spin on the week's events, saying Trevena believes the "totality of evidence" supports oliceridine's approval. Shareholders, however, don't appear to be putting much faith in its chances.
Oliceridine is Trevena's lead drug, and the company has presented it as a potentially safer intravenous opioid based on its more selective mechanism of action.
The advisory committee's negative review wasn't entirely unexpected, however. Brief documents issued by the FDA on Tuesday showed the the FDA hadn't agreed to a number of key points on the design of oliceridine's clinical program, including the measurement of respiratory safety burden.
Trevena later filed a notice with the Securities and Exchange Commission clarifying its past discussions with the regulator at an End of Phase 2 meeting.
If oliceridine fails to garner an OK, Trevena will be in a tough spot. The drugmaker has two other clinical-stage drugs poised to enter Phase 2, but its current cash holdings are only sufficient to fund operating expenses and capital expenditures for at least 12 months.
Should oliceridine win over the FDA against expectations, the company has requested classification as a Schedule II controlled substance, and would look to launch in the first half of 2019.