INSYS

Dronabinol Oral Solution

Dronabinol Oral Solution is a proprietary synthetic THC in an oral liquid formulation which may offer advantages, including more consistent bioavailability, faster onset of action and more flexible dose titration.

Drug Indication Preclinical Phase 1 Phase 2/3 NDA Approved
Fentanyl Sublingual Spray BTCP in Opioid Tolerant Patients
Dronabinol SG (Generic MarinolĀ®) 2nd Line CINV
Dronabinol Oral Solution (Pre-NDA) 2nd Line CINV

We have completed a pre-NDA meeting with the FDA, and a pivotal bioequivalence study in 2012. The current dronabinol formulations are characterized by a high PK variability profile and an onset of action that ranges from 30 minutes to one hour. Improving these endpoints is the focus of the clinical development program for the Dronabinol Oral Solution.