The European Medicines Agency (EMA) has approved the e-Lockout, the first ever fully-integrated electronic nasal drug delivery device to be approved by a US or European regulatory authority.
The e-Lockout was developed by Aptar Pharma, global drug delivery systems company, following a multi-year development with Takeda Pharmaceuticals International.
Aptar Pharma agreed to supply Takeda with its e-Lockout device for a multidose nasal spray version of Instanyl, available in unidose and multidose nasal spray versions.
The EMA has granted marketing authorisation for this multidose nasal spray treatment under the name Instanyl DoseGuard.
Takeda will launch Instanyl DoseGuard in Europe in several multidose strengths, all using Aptar Pharma’s electronic lockout system.
Instanyl is a fast-acting nasal opioid approved for relieving breakthrough pain in adult cancer patients already treated with opioids for their usual pain.
Breakthrough pain is an additional sudden pain that occurs despite having taken one’s usual pain relieving medicines.
Aptar Phama’s e-Lockout device uses electronic technology to ensure safe patient compliance by limiting the number of doses available during a 24 hour period.
How e-Lockout works
The system’s built-in lock-out mechanism prevents the device from being used for a period of time after a pre-defined number of spray actuations.
The electronic display shows the number of priming strokes, the number of doses left in the device and whether the nasal spray is locked or ready for use.
The e-Lockout also features a child-resistant cap.