A Phase 3, Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain for Which Parenteral Opioid Therapy is Warranted
Phase of Trial: Phase III
Latest Information Update: 07 Mar 2018
At a glance
- Drugs Oliceridine (Primary)
- Indications Pain; Postoperative pain
- Focus Adverse reactions; Registrational
- Acronyms ATHENA-1
- Sponsors Trevena
- 07 Mar 2018 According to a Trevena media release, Company announced top-line results in November.
- 07 Mar 2018 According to a Trevena media release,The Company anticipates the PDUFA date for the NDA will be November 2, 2018 and Company expects commercial launch of OLINVO in the first quarter of 2019 following DEA scheduling.
- 02 Jan 2018 According to a Trevena media release, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for OLINVO (oliceridine) Injection.The Company anticipates the PDUFA date for the NDA will be in the fourth quarter of 2018.