Aptar Pharma has announced that its partner Takeda Pharmaceuticals has received approval from the EMA to market a multidose version of its Instanyl fentanyl nasal spray that includes Aptar’s e-Lockout integrated electronic lockout device. According to Aptar, Takeda plans to market the product as Instanyl DoseGuard, though no launch date has been announced at this time.
Takeda acquired Instanyl nasal spray when it acquired Nycomed in 2011. Nycomed got European approval for 50, 100, and 200 mcg multi-dose versions of Instanyl for the treatment of breakthrough pain in cancer patients in 2009 and for a single-dose version in 2011.
According to Aptar Pharma, the e-Lockout, which is the first electronic lockout device integrated into a nasal spray approved in the US or Europe, acts as a dose counter in addition to limiting the number of actuations in a 24-hour period.
Aptar Pharma President Salim Haffar commented, “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. 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.”
Read the Aptar Pharma press release.