Zolpidem’s new formulation is currently under investigation through clinical trials (Phase II) and will be developed by Σellas Biopharma Neuro AG through the end of Phase II to seek out-licensing partners with big pharmaceutical companies for high premium return.
Further steps concerning Zolpidem include:
- Pre-IND meeting with FDA & IND submission planned for Q2 2013 in parallel with Health Authority Submission in Europe
- Fast-Track Designation by FDA planned in Q2 2013
- Orphan Drug Designation by FDA and EMEA planned in Q2 2013
- Clinical Study (Phase II) Initiation planned for Q2/Q3 2013
- Clinical Study (Phase II) Completion estimated by Q3 2014