Opiant Pharmaceuticals has taken another step toward filing for approval of its nasal opioid overdose drug. With the pharmacokinetic study showing the drug is absorbed quickly in the nose, Opiant remains on track to submit an application to the FDA later this year.
The drug candidate, OPNT003, is a nasal formulation of nalmefene, a molecule that won approval in an injectable form in the 1990s only to be pulled from the market around a decade later. Opiant is trying to resurrect the drug in the belief its half-life and affinity for opiate receptors make it a useful weapon in the fight against overdoses of synthetic opioids such as Fentanyl.
As part of a push to test that idea, Opiant ran a 23-subject pharmacokinetic study. The crossover design trial gave OPNT003 as a single 3-mg dose in one nostril, as a single dose in each nostril and as two doses in one nostril.
Opiant reported each regimen reached maximum concentration in 15 minutes. Plasma concentrations were proportional to dose, and the plasma half-life lasted up to 11 hours. Opiant expressed satisfaction with the results.
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“We are pleased that this study has met our objective of demonstrating safety, tolerability, and pharmacokinetic equivalence across multiple nasal doses,” Opiant CEO Roger Crystal, M.D., said in a statement. “These data are fully consistent with the rapid delivery of high plasma concentrations of nalmefene observed in our previous OPNT003-PK-001 study, which compared 3 mg nasal nalmefene to a previously approved intramuscular dose.”
Opiant ran the study at the request of the FDA and plans to include the data in a new drug application to the agency later this year. The filing will also include the results from an ongoing pharmacodynamic trial Opiant is running to compare nasal nalmefene to nasal naloxone in reversing respiratory depression produced by the synthetic opioid remifentanil.
Emergency response teams use nasal naloxone, sold under the brand name Narcan, to treat overdoses with opioids. Opiant developed Narcan and now receives royalties on sales by Emergent Biosolutions.