Case Study - Unidose Nasal Spray Pump for Opioid Overdose

Although naloxone has long been available in injection format as a treatment for opioid overdose, administration relies on the presence of a suitably trained responder. This case study describes a collaborative drug repurposing project with Aptar Pharma to develop an easy-to-administer naloxone nasal spray. The resulting product has been successfully commercialized to broaden access to a life-saving therapeutic. Utilizing Aptar Pharma’s Unidose Liquid (UDS) system, it is primeless, reliable, and intuitive. Collaboration accelerated time to market for the nasal spray via the FDA’s 505(b)(2) Abbreviated Approval Pathway (U.S.) creating valuable intellectual property. The global market for the product is in excess of $350 million (2021).