Opiant Pharmaceuticals announced that it has signed an agreement with Aptar Pharma for expanded production of Aptar’s Unidose device in order to support potential commercial demand for Opiant’s OPNT003 intranasal nalmefene. The agreement includes €2 million from Opiant for installation of the necessary production equipment. Opiant recently initiated a rolling NDA submission for OPNT003, following news that a PD study of OPNT003 had met its primary endpoint.
OPNT003 was initially delivered via Bespak’s Unidose Xtra device; however, Opiant announced in October 2020 that it was switching to the Aptar UDS device. The Aptar device is also used by Opiant for delivery of Narcan naloxone nasal spray, which was approved by the FDA in November 2015.
Opiant President and CEO Roger Crystal commented, “This capacity investment with Aptar demonstrates Opiant’s commitment to ensure adequate supply of OPNT003 nasal nalmefene to communities and emergency responders as quickly as possible, if approved.”
Read the Opiant Pharmaceuticals press release.