Opiant Pharmaceuticals shared a set of results from its Phase 1 trial of OPNT002.
Opiant Pharmaceuticals (OTCQB:OPNT) shared a set of results from its Phase 1 trial of OPNT002.
As quoted in the press release:
This study was conducted under a clinical trial agreement between Opiant and the National Institute of Drug Abuse (NIDA), a division of the National Institutes of Health (NIH). The study examined the effects of Intravail®, an absorption enhancer, on the pharmacokinetic properties of IN naltrexone in healthy volunteers. The trial also assessed the safety of IN naltrexone, particularly with respect to nasal irritation. Opiant has also signed an agreement with Renaissance to initiate work on the product development.
Some notable Phase 1 findings include:
- Intravail®, recently licensed by Opiant from Aegis Therapeutics, increased the maximal plasma concentrations (Cmax) of IN naltrexone by almost three-fold compared to IN naltrexone alone.
- The addition of Intravail® significantly accelerated the time (Tmax) to reach maximum observed plasma concentrations of naltrexone, from 30 minutes to 10 minutes.
- No safety or tolerability concerns were identified; there was no evidence of nasal irritation.