Opiant Pharmaceuticals, Inc. (OPNT) stock prices were up a significant 32.54% shortly after market trading commenced on July 7th, 2021, bringing the price per share up to USD$17.57
July 7th, 2021 saw the company announce top-line results from its confirmatory pharmacokinetic study for the nasal nalmefene, OPNT003, for use in cases of opioid overdose. The study had a total enrollment of 68 subjects and was designed to compare 3mg nelmafene nasal spray with 1mg intramuscular nalmafene injection. As per an initial analysis, nasal nalmefene reported significantly higher plasma concentrations as compared to the intramuscular injections. A previously completed pilot study pegged the time for nasal nalmefene to achieve maximum plasma concentrations at 15 minutes, with the finding being consolidated in the OPNT003 study.
Currently, the only treatment for opioid overdose that has been approved by the FDA is Naloxone, which has a half life of roughly 2 hours. April saw the company initiate a pharmacodynamic study in healthy subjects, which was designed to compare OPNT003 with nasal naloxone in reversing the respiratory depression produced by the synthetic opioid remifentanil.
Pushing for Commercialization
Topline data from the study is expected in the fourth quarter of 2021. Accordingly, OPNT is expecting to submit a marketing application to the U.S Food and Drug Administration by the first quarter of 2022 at the latest. OPNT003 development has been facilitated by grants from the National Institute on Drug Abuse and the Biological Advance Research and Development Agency.
Scope of OPNT003
Opioid overdoses have reached unprecedented levels of being the cause of deaths, with the Centers for Disease Control and Prevention reporting more than 69,000 opioid overdose deaths in the 12 months through November 2020. 80% of these are linked to potent illicit synthetic opioids, especially fentanyl. 2017 saw the NIH leadership call for opioid reversal agents that were longer lasting and stronger, as a response to the potency of synthetic opioids in the interest of controlling the proliferation of the public health crisis.
Future Outlook for OPNT
Armed with the successful results of its OPNT003 study, OPNT is poised to push for the commercialization and proliferation of its flagship treatment. The company is keen to establish an expansive market footprint, while addressing a rising cause of concern for public health.