FDA Approves Manhattan's Phase I Trials for Propofol Lingual Spray

The FDA has accepted an investigational new drug (IND) application from Manhattan Pharmaceuticals for the initiation of the human clinical trials required for FDA approval of Propofol Lingual Spray (Propofol LS).

Propofol LS is being jointly developed with NovaDel Pharma as a fast-acting, quick-recovery sedative for use during diagnostic and therapeutic procedures. Manhattan continues to pursue FDA approval for Propofol LS under a 505(b)2 regulatory pathway.

In July 2004, a pilot Phase I safety, tolerability, and pharmacokinetic study was completed in the UK. The results of this study support the feasibility of propofol delivery by the oral mucosal route and provided valuable data critical to the design of the clinical trials Manhattan intends to conduct under this IND.