FDA Fast Tracks KemPharm’s KP511

The FDA has awarded fast track-designation to KemPharm’s investigational hydromorphone candidate KP511, which is being developed as an extended-release prodrug to manage severe pain.

The company plans on submitting an NDA application for the candidate, which is designed to be bioequivalent to currently available extended release hydromorphone products, in 2018.

The candidate uses ligand activated therapy technology to create abuse-deterrent characteristics at the molecular level.