Opiant Pharmaceuticals (OPNT), a specialty pharmaceutical company, and Consort Medical, a contract development and manufacturing organization, unveiled on Monday a development and manufacturing agreement for Opiant’s OPNT003 (intranasal nalmefene), a potent, long-acting opioid antagonist for the treatment of opioid overdose.
Under the agreement, Aesica and Bespak, units of Consort, will work with Opiant to produce a pre-filled delivery nasal spray with nalmefene, Opiant said in a statement.
Aesica will also supply Opiant with clinical samples and registration batches for the purposes of performing clinical studies and obtaining regulatory approvals.
Further, upon approval by the FDA, Aesica and Bespak will manufacture and supply the commercial device for Opiant.
Opiant said it seeks to start a confirmatory pharmacokinetic study early next year, following the completion of OPNT003 formulation studies.
Opiant said it anticipates the potential to submit a new drug application for the drug and intranasal delivery device combination in 2020.
Opiant said it retains full commercial rights to OPNT003, and this development work is largely funded by a $7.4 million National Institutes of Health (NIH) grant.