A Human Abuse Potential Trial of Intranasal Serdexmethylphenidate
Phase of Trial: Phase I
Latest Information Update: 11 Apr 2019
Price : $35 *
At a glance
- Drugs Serdexmethylphenidate (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Pharmacodynamics; Registrational
- Sponsors KemPharm
- 11 Apr 2019 According to a KemPharm media release, the company has concluded a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for KP415. The FDA confirmed the clinical and non-clinical requirements for its submission, and the company is now on track for submission in late Q2 or early Q3 2019.
- 24 Oct 2018 According to a KemPharm media release, data from the study will be presented at the 65th Annual American Academy of Child and Adolescent Psychiatry (AACAP) Meeting 2018.
- 24 Oct 2018 Results presented in a KemPharm media release.