Consort Medical subsidiaries Aesica and Bespak will manufacture Opiant Pharmaceuticals’ OPNT003 nalmefene nasal spray, the companies said.
Earlier this year, Opiant announced that it would develop OPNT003 for the treatment of opioid overdose using the 505(b)(2) pathway, and the company has been awarded a grant worth around $7.4 million by the National Institutes of Health’s National Institute on Drug Abuse (NIDA) for development of the product.
Opiant says that it expects to initiate a PK study early next year, with an NDA submission planned for 2020.
According to the agreement with Consort, Aesica will produce clinical supplies and registration batches, and Aesica and Bespak will manufacture the commercial device if the nasal spray is approved by the FDA.
Opiant CEO Roger Crystal said, “We are extremely pleased to be working with a group as highly-regarded as the Consort team. OPNT003 has the potential to be a transformative treatment for opioid overdose, and Consort’s significant expertise in inhalation technologies will help support our lead product candidate through commercialization.”
Consort CEO Jonathan Glenn commented, “We are delighted to announce this agreement with Opiant, which highlights our expertise in the nasal delivery of drugs and the value of our unique offering of providing both drug manufacturing and delivery capabilities alongside one another.”
Read the Opiant and Consort Medical press release.
