EMA Approves First Electronic Lockout Device for Pain Management

Aptar Pharma announced that the European Medicines Agency (EMA) have approved its integrated electronic nasal lockout device (e-Lockout) following years of development with Takeda Pharmaceuticals International AG. Aptar Pharma has agreed to supply Takeda with its e-Lockout device for a multidose nasal spray version of Instanyl (fentanyl) used in pain management.

EMA has granted marketing authorization for this multidose nasal spray treatment under the name Instanyl DoseGuard. Takeda will launch Instanyl DoseGuard in Europe in several multidose strengths, using Aptar Pharma’s patented electronic lockout system. The approval represents a major milestone for Aptar Pharma, with the e-Lockout device being the first and only fully integrated electronic nasal drug-delivery device to be approved by EMA.

Instanyl is a fast-acting nasal opioid for relieving breakthrough pain in adult cancer patients already treated with opioids for their usual pain. Aptar Phama’s e-Lockout device uses advanced electronic technology to limit the number of doses available during a 24-hour period, thereby ensuring safe patient compliance. A 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.

The multi-year supply agreement reinforces a long-standing partnership between Takeda and Aptar Pharma. Aptar Pharma currently supplies Takeda with unidose and multidose nasal spray devices for Instanyl in Europe.

Source: Aptar Pharma