Opiant Pharmaceuticals has signed a manufacturing agreement with Consort Medical for its OPNT003 (intranasal nalmefene), a potent, long-acting opioid antagonist for treating opioid overdose.
Under this agreement, Aesica and Bespak, wholly-owned subsidiaries of Consort, will work with Opiant to produce a pre-filled delivery nasal spray with nalmefene.
As part of the agreement, Aesica will supply Opiant with clinical samples and registration batches for the purposes of performing clinical studies and obtaining regulatory approvals.
Further, upon approval by the US Food and Drug Administration (FDA), Aesica and Bespak will manufacture and supply the commercial device for Opiant.
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 said: “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.”
Following the completion of OPNT003 formulation studies, Opiant intends to initiate a confirmatory pharmacokinetic study in early 2019. Based on previously obtained feedback from the FDA, Opiant intends to pursue a 505(b) (2) development path for OPNT003. Opiant anticipates the potential to submit a New Drug Application for the drug and intranasal delivery device combination in 2020. Opiant retains full commercial rights to OPNT003, and this development work is largely funded by a $7.4m National Institutes of Health (NIH) grant.
Source: Company Press Release.