Particle Sciences Develops Proprietary Nasal Delivery Formulation Used in Neurelis' Recently Announced Successful Phase I Pharmacokinetic Study of NRL-01 (intranasal diazepam)
In a recent announcement by Neurelis, a proprietary intranasal formulation of diazepam (NRL-1) achieved positive clinical results in a Phase I pharmacokinetic study. The propriety formulation was designed and manufactured at Particle Sciences. In the Phase 1 clinical trial NRL-1 demonstrated a pharmacokinetic profile comparable to that reported in the literature for Diastat (rectal diazepam gel), the only FDA approved therapeutic product for home treatment of acute repetitive seizures. The bioavailability of the NRL-1 intranasal formulation was 96%.
According to Dr. Robert Lee, Particle Sciences VP of Pharmaceutical Development, "We are obviously very pleased with the results Neurelis have obtained. It has been a pleasure working with them and very rewarding to contribute to a product that should truly improve the quality of life for patients with acute repetitive seizures and their caregivers. We were able to achieve extremely high levels of solubilized diazepam using our DOSE® platform that combines empirically obtained data with customized solubility software. This approach along with Particle Sciences' cGMP analytical and manufacturing services have enabled our clients to more rapidly advance to the clinic with commercially viable formulations."
David F. Hale, Chairman of Neurelis, said that "The team at Neurelis was very pleased with the work on the formulation conducted by Particle Sciences. They really focused on a key issue with diazepam which is solubility and developed two proprietary formulations which we evaluated in the clinical trial. Based on the results obtained in the clinical trial we plan to move ahead with the further development of this product candidate for patients with epilepsy who have acute repetitive seizures."