Opiant Pharmaceuticals said that it has terminated an agreement for the use of Bespak’s Unidose Xtra device for delivery of its OPNT003 intranasal nalmefene for the treatment of opioid overdose and has entered into a new agreement with Aptar Pharma for the use Aptar’s Unit Dose System (UDS) to deliver OPNT003. Opiant already uses the UDS for delivery of its Narcan naloxone nasal spray, which was approved by the FDA in November 2015.
In September 2018, Opiant announced a deal with Aesica and Bespak for manufacturing of OPNT003. At the time, Aesica and Bespak were owned by Consort Medical, which was acquired by Recipharm a little more than a year later.
Opiant says that it intends to file a 505(b)(2) NDA for OPNT003 by the end of 2021. Funding for development of the drug has been provided by the NIH and the Biological Advance Research and Development Agency (BARDA), which the company says “are interested in its potential as an antidote for use in a civilian mass casualty event.”
Opiant President and CEO Roger Crystal said, “We believe our decision to partner with Aptar’s proven nasal delivery system represents a timely and strategic step forward for Opiant as we continue to advance OPNT003 as a potentially life-saving treatment for opioid overdose in the face of America’s worsening opioid epidemic.”
Read the Opiant press release.
