Thursday, June 09, 2022
Opiant Pharmaceuticals, Inc. today announced a capacity investment agreement with Aptar Pharma (Aptar), a leading provider of drug delivery systems, to expand production of Aptar’s nasal Unidose device, which will be used in the production of commercial supply of OPNT003, nasal nalmefene.
The agreement includes an investment by Opiant of €2 million (approximately $2.1 million) and a commitment by Aptar to install and maintain equipment in support of increased future production of its Unidose device to meet the potential commercial demand for OPNT003, nasal nalmefene.
“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,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant.
Opiant has initiated rolling submission of a New Drug Application to the U.S Food and Drug Administration (FDA), for OPNT003, nasal nalmefene, for the treatment of opioid overdose, using the 505(b)(2) pathway. It intends to complete its application in the second half of 2022. Opiant was granted Fast Track Designation in November 2021.