Trevena`s Opioid Painkiller Fails to Get FDA Panel Backing

By Reuters Staff

(Reuters) - Trevena Inc's opioid injection for managing acute pain failed to win the backing of an advisory panel to the Food and Drug Administration on Thursday, against the backdrop of opioid addiction in the United States reaching epidemic proportion.

The panel voted 8-7 against the drug oliceridine, which is administered in hospitals and ambulatory surgery centers and aims to manage acute pain in patients for whom an intravenous opioid is necessary.

"We just don't have enough safety data to say that we are not going to inadvertently harm people," said Mary Ellen McCann, a panel member and associate professor of Anesthesia Harvard Medical School.

"If this drug is brought up in another half a year or a year with better, more data, I would be very happy to vote yes."

The decision comes two days after FDA staff reviewers said overall assessment of the abuse-related data suggested the treatment has an abuse and overdose potential and could lead to physical dependence similar to other such treatments.

The FDA will decide the fate of oliceridine by November 2. The regulator is not obligated to adhere to the panel's recommendations, but typically does.

Oliceridine belongs to the same class of opioids as commonly prescribed painkillers such as morphine and fentanyl.

Trading in the shares of the company were halted.

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