According to Opiant Pharmaceuticals, a pharmacodynamic study of the company’s OPNT003 intranasal nalmefene met its primary endpoint of non-inferiority compared to intranasal naloxone, with 3 mg of OPNT003 almost twice as effective as 4 mg of naloxone in reversing respiratory depression caused by a synthetic opioid at 5 minutes post dose.
OPNT003, which is delivered via Aptar Pharma’s Unit Dose System (UDS) device, was granted Fast Track designation in November 2021. The company is developing OPNT003 under a contract with the Biomedical Advanced Research and Development Authority (BARDA)
Opiant President and CEO Roger Crystal commented, “We are thrilled to be sharing positive topline data from our head-to-head PD study comparing OPNT003, nasal nalmefene, with nasal naloxone. These data, taken together with our prior PK studies, suggest that OPNT003 could be well suited to address the challenges in treating today’s opioid overdoses, which are driven by synthetic opioids, like fentanyl. It is extremely rewarding to see this program yield clear, consistent, results, and we look forward to continuing to work towards submitting our new drug application, which we anticipate occurring in the second half of this year.”
Read the Opiant Pharmaceuticals press release.
