Proprietary nasal delivery formulation of diazepam reaches NDA7 Nov 2018
The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial.
A proprietary nasal delivery formulation of diazepam for the treatment of epilepsy developed by CDMO, Particle Sciences, a Lubrizol LifeSciences company, has been submitted as a New Drug Application (NDA) to the FDA by San-Diego-based Neurelis.
Valtoco, previously referred to in clinical development as ‘NRL-1’, is the lead product candidate of Neurelis, which worked closely with Particle Sciences on the formulation of the diazepam nasal spray designed to treat acute repetitive seizures in patients over the age of six.
Using its Dose platform that combines empirically obtained data with customized solubility software based on Hansen solubility parameters, Particle Sciences was able to achieve extremely high levels of solubilized diazepam using a benign vehicle that is compatible with nasal delivery. The resulting absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial of healthy volunteers.
The NDA for Valtoco is a 505(b)(2) filing utilizing rectal diazepam gel, the only currently FDA approved therapeutic product for home treatment of acute repetitive seizures, as the Reference Listed Drug. The NDA is supported by further extensive clinical studies in healthy volunteers and patients with epilepsy, with more than 1,600 seizures treated to date with the nasal spray.
Dr Robert Lee, president of Particle Sciences said: “It’s rewarding to see Valtoco reach this key milestone after Neurelis’ successful clinical trials. This product will bring positive improvements to the lives of many patients with acute repetitive seizures”.
Lee added: “Nasal delivery is often an overlooked route of administration, but it can offer an ideal route and increase bioavailability for several drug types, particularly those designed to treat diseases of the central nervous system. We are seeing real growth in this area and expect to see an increase in demand for nasal formulations in the future as we continue to focus on the development of complex drug products.”
Craig Chambliss, President and CEO of Neurelis said: “Having assessed dozens of formulation approaches for solving the challenges with delivering intranasal benzodiazepines for epilepsy patients, we partnered with Particle Sciences to leverage their experience and expertise in solving for a formulation issue that has kept poorly soluble drugs from being developed for significant unmet clinical needs.”
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