EMA OKs Aptar’s Electronic Nasal Lockout Drug-Delivery Device
Aptar Pharma, a provider of drug-delivery systems, has received approval by the European Medicines Agency of an integrated electronic nasal lockout device (e-Lockout) following a multi-year development with Takeda Pharmaceuticals International AG. Aptar Pharma agreed to supply Takeda with its e-Lockout device for a multidose nasal spray version of Instanyl (fentanyl).The EMA has granted marketing authorization for this multidose nasal spray treatment under the name Instanyl DoseGuard.
Already available in unidose and multidose nasal spray versions, Takeda will launch Instanyl DoseGuard in Europe in several multidose strengths using Aptar Pharma’s electronic lockout system.
Instanyl is a 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 advanced electronic technology to help patient compliance in the treatment of chronic disease. Aptar Pharma’s e-Lockout device is intended to ensure safe patient compliance by limiting the number of doses available during a 24 hour period. 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.
Source: Aptar Pharma