Opiant Pharmaceuticals has secured up to $3.5 million from the U.S. government to advance clinical development of its nasal opioid overdose drug OPNT003. The nasal drug delivery specialist is taking the candidate forward in the belief nalmefene has advantages over the currently used naloxone.
Nalmefene is used in Europe in patients with alcohol dependence but in the U.S. is better known as an antidote to opioid overdoses. The FDA approved an injectable formulation of the drug in 1995, only for Baxter to discontinue the product, Revex, in 2008.
Despite Baxter failing to make a success of Revex, the half-life of nalmefene and its affinity for opiate receptors led Opiant to identify it as a potential response to the ongoing opioid crisis. Opiant sees the characteristics of nalmefene as particularly suitable for use in the response to overdoses of fentanyl, the potency and half-life of which can overwhelm naloxone.
Opiant has persuaded the Biomedical Advanced Research and Development Authority (BARDA) of the potential of its approach. Having previously awarded Opiant a contract worth up to $4.6 million, BARDA recently added $3.5 million to the value of the agreement.
California-based Opiant said the additional funding will enable it to advance clinical development of OPNT003. Specifically, Opiant will use the money to run a pharmacodynamic study and carry out development work associated with its use of Aptar Pharma’s Unit Dose System.
Development of OPNT003 was held up early this year when the FDA put a pharmacokinetic study on clinical hold pending the assessment of the delivery device. The FDA lifted the clinical hold in May, but the delay, which lasted almost five months, will prevent Opiant from delivering on its old plan to file a new drug application this year. Opiant is now on track to file by the end of 2021.
Opiant, formerly Lightlake Therapeutics, developed Narcan, the nasal naloxone formulation used to treat opioid overdoses today, before licensing it out in 2014.