A clinical validation study of PatchPump used by Trevyent in healthy adult volunteers.
Phase of Trial: Phase I
Latest Information Update: 02 Apr 2018
At a glance
- Drugs Treprostinil (Primary)
- Indications Pulmonary arterial hypertension
- Focus Adverse reactions
- 02 Apr 2018 According to a Cardiome Pharma media release, the company's partner SteadyMed Therapeutics, will resubmite a NDA for Trevyent to FDA. This resubmission is based on the FDA's feedback after an in-person Type A meeting and the certain in vitro pre-design verification (pre-DV) tests. SteadyMed expectes for filing by the end of 2018. Cardiome Pharma plans to submit a regulatory filing for Trevyent in Europe shortly following SteadyMed's NDA resubmission to the FDA.
- 13 Nov 2017 According to a SteadyMed Therapeutics media release, company held an in-person Type A meeting with FDA and has agreed to a path forward with FDA that it expects will allow for the resubmission and acceptance of Trevyent NDA.
- 28 Sep 2017 According to a SteadyMed Therapeutics media release, the company has submitted a Type A Meeting Request and Briefing Document to the U.S. Food and Drug Administration (FDA) in response to a Refusal to File letter relating to its New Drug Application (NDA) for Trevyent.