First human trial of KP 511 for the treatment of severe pain
Phase of Trial: Phase I
Latest Information Update: 10 May 2016
At a glance
- Drugs Asalhydromorphone (Primary)
- Indications Pain
- Focus Adverse reactions
- Sponsors KemPharm
- 10 May 2016 According to a KemPharm media release, KP511 has been granted Fast Track designation by the US FDA. KemPharm plans to seek approval of KP511/ER under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act with an anticipated New Drug Application (NDA) submission as early as 2018.
- 10 May 2016 Status changed from not yet recruiting to recruiting, according to a KemPharm media release.
- 28 Mar 2016 According to a KemPharm media release, the company has received clearance from the US FDA to initiate human clinical trials of KP511 and expect to initiate the clinical trials in the second quarter of 2016.