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Trevena gets second go at FDA approval for pain drug

FDA sets review completion date of 7 August 2020


US biotech Trevena has resubmitted its lead drug oliceridine for moderate-to-severe pain in the US, 18 months after it was turned down by a Food and Drug Administration (FDA) advisory committee.

The FDA has set a date of 7 August to complete its review of the marketing application for the intravenously-administered drug, a mu-opioid receptor agonist which is billed as a new class of painkiller.

The new review – which the FDA considers a class two resubmission so will take less time to complete – is “the crucial next step to bringing oliceridine to patients”, said Trevena’s chief executive Carrie Bourdow.

The FDA’s advisory committee voted 8 to 7 against recommended approval of oliceridine in October 2018, with some panellists expressing concern about adverse events with the drug including QT prolongation, which can indicate an adverse effect on the heart.

They also said the proposed dosing for the drug may not be sufficient to treat moderate to severe pain, as oliceridine was unable to show a significant improvement on the active comparator used in clinical trials.

Some concluded there wasn’t enough data on side effects like respiratory depression compared to equivalent doses of current opioids such as morphine – even though oliceridine was specifically developed to reduce the risk of respiratory and gastrointestinal side effects seen with other opioid painkillers.

The FDA agreed with that assessment, and issued a complete response letter (CRL) in November 2018 which asked for additional clinical data on QT prolongation and said the safety database for the drug wasn’t big enough for the proposed dose range.

Rubbing further salt into the wounds, the FDA then withdrew its breakthrough designation for oliceridine last year, saying that the phase 3 data for Trevena’s drug weren’t strong enough to warrant that status.

Trevena carried out a phase 1 trial to back up the safety of the drug on the QT prolongation issue, and has agreed to refile with a maximum daily dose of 27mg, which the FDA said was covered by its safety data.

The company says oliceridine matches the analgesic efficacy of current opioids, has a rapid onset of action (within five minutes) and doesn’t need any dosage adjustments for the elderly or people with kidney impairment.

The Pennsylvania biotech also updated investors on its cash reserves, saying it still had around $36m in hand at the end of 2019, which should be enough to see it through the FDA’s review of oliceridine and the first quarter of next year.

Article by
Phil Taylor

6th March 2020

From: Regulatory



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