Aptar Pharma said today that the European Medicines Agency approved its electronic nasal lockout device, e-Lockout. The device is the 1st and only fully-integrated electronic nasal drug delivery device to be approved by a European regulatory authority, according to the company.
The e-Lockout device is a part of a multi-year development deal with Takeda Pharmaceuticals International (TYO:4502). Aptar agreed to supply its e-Lockout device for use with Takeda’s multi-dose nasal spray version of a fast-acting opioid, Instanyl.
Takeda plans to launch a uni-dose and multi-dose version of its nasal spray with Aptar’s electronic lockout system in Europe.
The device is intended to limit the number of doses available during a 24-hour period, in the hopes of boosting patient compliance.
Instanyl is indicated as a pain-reliever for breakthrough pain in adult cancer patients who are already taking opioids for their usual pain. Breakthrough pain refers to additional sudden pain that happens even though patients take their usual painkillers
Aptar’s e-Lockout device uses an electronic mechanism to prevent the device from being used for a period of time after a pre-defined number of doses. The display shows the number of doses left in the device and whether the spray is locked or available for use. The device also has a child-resistant cap.
“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,” Aptar Pharma’s president, Salim Haffar, said in prepared remarks. “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.”
