Hier die Zusammenfassung von Seeking Alpha:

The FDA review team believes that oliceridine has high abuse potential. In addition, per page 93 in the FDA document, oliceridine "looks slightly less efficacious" than morphine (0.5 mg dose) but exhibits "similar rates" of dizziness, hypoxia, nausea and vomiting.

A negative vote from the committee appears virtually certain considering the present opioid crisis.

Hab wie gesagt das Dokument noch nicht selbst gelesen und kann deswegen nicht sagen, wie viel Wahrheit drin steckt.

FDA hat Sicherheitsbedenken vom dem Panel am 11. Oktober

https://www.streetinsider.com/Corporate+News//...ridine/14685788.html

https://www.ariva.de/news/...ted-by-block-amp-leviton-llp-for-7192602

On May 2, 2016, the Company announced that it had "reached general agreement" with the FDA on key elements of its Phase 3 program for oliceridine (TRV130) and was "very pleased" with the outcome of its discussions with the FDA.

In fact, FDA minutes from its April 28, 2016 meeting with the Company—revealed today—show that the FDA:

• "did not agree with the proposed dosing in the Phase 3 studies";
• "did not agree with the proposed primary endpoint"; and
• "did not agree with the proposed non-inferiority (NI) margin for comparing morphine to oliceridine"