Replies to post #209857 on Amarin Corp Plc (AMRN)

[Atom0aks]

Oliciderine.

You're surprised that an opioid was rejected while we are in the midst of a huge opioid epidemic?

In case you weren't aware, the FDA is currently overhauling approval guidelines for ALL opioids (https://www.fda.gov/drugs/development-approval-process-drugs/standards-future-opioid-analgesic-approvals-and-incentives-new-therapeutics-treat-pain-and-addiction).

[sts66]

This drug appears to be an IV version of Tramadol, which I have a prescription for - and I can tell you first hand what the company claims is true (zero similarity to opiates because of unique MOA), and what the FDA said is bullcrap - this was a knee jerk reaction in the midst of any opiod epidemic - but they had no problem approving Dsuvia a month later (10 times stronger than fentanyl) in part because the US military wanted it for battlefield injuries.

The FDA has declined to approve Trevena’s oliceridine, a mu-opioid receptor modulator for the treatment of moderate to severe pain. The complete response letter comes three weeks after an FDA advisory committee voted narrowly against the drug’s approval.

Oliceridine, given the brand name Olinvo, works differently than conventional opioids, the company says. It uses a different pathway to relieve pain without causing respiratory and gastrointestinal side effects that limit other pain meds.

The FDA was not convinced, saying that Trevena had not submitted adequate safety data to support its proposed dosing. Furthermore, FDA staff outlined in briefing documents released ahead of the advisory committee meeting on Oct. 10 that it has “abuse potential, overdose potential and ability to produce physical dependence that is similar to other (opioids).” The panel came down 8-7 against oliceridine, sending the company’s stock down 64%.

Curious as to who you think was the outside influencer in this case?