Opiant Pharmaceuticals has announced that, based on feedback from the FDA and positive data from a Phase I clinical study, the company plans to pursue a 505(b)(2) development path for its OPNT003 intranasal nalmefene for the treatment of opioid overdose. OPNT003 is formulated using Aegis Therapeutics’ Intravail absorption enhancer, which Opiant licensed in 2017.
According to Opiant, a Phase 1 study of OPNT003 demonstrated that the intranasal formulation produced a faster onset than intramuscular injection with “rapid increases in plasma levels.” In addition, the company pointed out that the half-life of the intranasal formulation was 6.7-7.8 hours compared to 2 hours for an injection, which is in line with recent calls by NIH for longer-acting opioid antagonists.
The company also said that it has applied for a grant from the National Institutes of Health (NIH) to fund development of the product.
Opiant CEO Roger Crystal commented, “We are pleased with the positive outcome of this meeting and the beneficial guidance received from the FDA. We now have a well-defined development and regulatory pathway to pursue approval of OPNT003 in the US for the treatment of opioid overdose. Following the feedback received from the FDA, we are focused on leveraging the 505(b)(2) development pathway that allows certain information required for NDA approval to be derived from studies not conducted by Opiant. We anticipate submitting an NDA for OPNT003 in 2020. Based on its profile and the Phase I trial results, we believe OPNT003 has the potential to be a transformative treatment for opioid overdose, a growing US health epidemic.”
Read the Opiant press release.