Shares of biopharmaceutical company Opiant Pharmaceuticals Inc. (OPNT) are soaring 63 percent higher in Tuesday’s after-market trading after the company reported positive top-line results for Nasal Nalmefene, its investigational treatment for Opioid overdose.
The company announced encouraging results from its confirmatory pharmacokinetic or PK study for OPNT003, nasal nalmefene, for opioid overdose.
The study was done on 68 healthy subjects and compared OPNT003, nalmefene hydrochloride nasal spray, 3 mg, with a 1 mg intramuscular nalmefene hydrochloride injection. The study was conducted as per the directions of the U.S. Food and Drug Administration.
As per the preliminary analysis, the top-line data revealed that nasal nalmefene achieved higher plasma concentrations in comparison with the intramuscular injection. The time for nasal nalmefene to achieve maximum plasma concentrations was consistent with data from the previously completed pilot study.
In April this year, the company began a pharmacodynamic study in healthy subjects comparing OPNT003 with nasal naloxone in reversing the respiratory depression produced by the synthetic opioid, remifentanil.
The company expects the availability of top-line data in the later half of the year. Both PK and PD data will form the basis of a new drug application submission using the 505(b)(2) regulatory pathway earlier agreed upon with the FDA by 2021 or 2022 end.
The stock is trading at $21.71, up $8.43 or 63% in Tuesday’s after-market trade.
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