Trevena Inc (NASDAQ: TRVN) revealed some crucial details regarding its collaboration with its China partner called Jiangsu Nhwa Pharmaceutical. Its partner has successfully enrolled its first patient in a Phase 3 trial for OLINVYK (oliceridine) injection.
The nature of the OLINVYK (oliceridine) injection
The substance in question happens to be a novel IV analgesic, and it is interesting to note that it has already been approved by the Food and Drug Administration (FDA). It happens to be a substance with the capacity to help patients struggling with acute pain.
It is the kind of pain that is severe enough to compel the patients to turn to an intravenous opioid analgesic. Unfortunately, many patients continue suffering from such pain, and it is rather frustrating considering that they can hardly access alternative treatments.
The President and CEO of Trevena Carrie Bourdow opines, “We are committed to delivering OLINVYK to patients and healthcare providers in need of alternative acute pain treatment options, both through our ongoing launch in the U.S. as well as our global partnerships,” said Carrie Bourdow, President and CEO of Trevena.”
Bourdow congratulates Nhwa, outlining that it isn’t easy striking such an outstanding clinical development milestone. He speaks out on behalf of Trevena Inc, indicating that they will continue offering the needed support to their partner. He outlines that a great deal of their focus will be geared towards helping the partner secure FDA approval OLINVYK in China.
The double-blind and actively controlled study in question is designed in such a way that it will involve 160 patients following abdominal surgery. It will consist of two arms. The first one happens to be the tan IV morphine positive control arm and the other an OLINVYK arm.
According to reports, the Chinese National Medical Products Administration (NMPA) determined a lot about the study’s design. Nhwa looks forward to completing the study to continue its efforts to submit its product to regulatory approval in China.