Pharmaceutical Business review

FDA accepts Orexo Zubsolv new drug application

Orexo, which expects the Zubsolv approval in July 2013, schedules the launch for September 2013.

Orexo president and CEO Anders Lundstrom said, "We have a good chance of becoming the first company to offer an alternative treatment option to Suboxone, which is today the leading product in the US market for the treatment of opioid dependence."

The company began clinical development and product life cycle management programs to assess Zubsolv’s healing potential as opioid dependence therapy.

Programs will document the treatment adherence and patient experiences during the Zubsolv treatment period.

Orexo is also expected to finish documenting additional dose strengths besides offering another flavor.