Aptar Pharma’s Electronic Lockout Device Approved by EMA

Aptar Pharma has received approval by the European Medicines Agency (EMA) of the first 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. The EMA has granted marketing authorization for this multidose nasal spray treatment under the name Instanyl DoseGuard.

This 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 a U.S. or European regulatory authority.

Already available in unidose and multidose nasal spray versions, Takeda will launch Instanyl DoseGuard in Europe in several multidose strengths, all using Aptar Pharma’s patented electronic lockout system, which marks another product innovation in the management of breakthrough pain.

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 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 lockout 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, who currently supplies Takeda with unidose and multidose nasal spray devices for Instanyl in Europe.

"This approval and subsequent product launch underscores Aptar Pharma’s ability to partner with the pharma industry to bring innovative, compliant and safer devices through the regulatory authorization process," said Salim Haffar, president, Aptar Pharma. "This is yet another example of Aptar Pharma’s expertise and technology at the heart of a new market launch. This is a significant step in strengthening Aptar Pharma’s credentials in the electronics and connected health markets. We are pleased to be building on our trusted, long-term partnership with Takeda."