NPL-2505: Novel reformulation

The program

By virtue of our collaboration with Catalent, Neuropharm has identified an opportunistic reformulation of a high volume pharmaceutical agent to allow for increased usage in a specific under-served patient population.

Our progress

Plans have been developed to file a NDA during the second half of 2011.

Regulatory

An abbreviated approval pathway will allow for lower development costs and a shortened time to market.

Neuropharm intends to seek marketing authorization consistent with a single-sourced agent; not generally subject to automatic substitution.

Market Opportunity

This reformulation will be based on an already established high-volume prescription therapeutic with a proven safety and efficacy profile. The new form will better meet the needs of a currently underserved patient sub-population.