Opiant Pharmaceuticals said that a PK study of its OPNT003 intranasal nalmefene, which it is developing for opioid overdose, demonstrated that the Tmax of the nasal formulation was about 15 minutes, similar to that shown in a previous pilot study, and Cmax was slightly higher than for an intramuscular injection of nalmefene and higher than in the pilot study. The study enrolled 68 subjects and evaluated a 3 mg dose of OPNT003 to a 1 mg dose of IM nalmefene.
The company also said that it initiated a PD study in April 2021 that is comparing OPNT003 to intranasal naloxone for the reversal of respiratory depression caused by remifentanil. Top line data from that study are expected to be available in the fourth quarter of 2021, and the company said that it expects to submit a 505(b)(2) NDA for OPNT003 at the end of 2021 or in the first quarter of 2022.
OPNT003 is formulated with Intravail absorption enhancer, which Opiant licensed from Aegis Therapeutics in 2017. In October 2020, Opiant announced that it was switching the delivery device for the product from Bespak’s Unidose Xtra to the Unit Dose System (UDS) from Aptar Pharma. Funding for development of the nasal spray has been provided by the National Institute on Drug Abuse and the Biological Advance Research and Development Agency. (BARDA).
Opiant President and CEO Roger Crystal commented, “We are very pleased with the results of this confirmatory PK study. Importantly, the data are consistent with the findings of our initial pilot study. In the United States, where we’ve seen the opioid epidemic worsen during COVID-19, the nationwide spread of potent illicit synthetic opioids, such as fentanyl, which is 50 times stronger than heroin, with a half-life more than seven hours, is driving significant numbers of opioid overdose deaths. A rescue agent with a rapid onset and a long half-life, is critical to saving lives from overdose. We now look forward to the PD data later in the year.”
Read the Opiant Pharmaceuticals press release.
