VALTOCO, a proprietary nasal delivery formulation, has been submitted as a New Drug Application (NDA) to the FDA in the US
Particle Sciences has announced that a proprietary nasal delivery formulation of diazepam for the treatment of epilepsy has been submitted as a New Drug Application (NDA) to the US Food and Drug Administration (FDA). The submission was made by San-Diego-based Neurelis Inc.
Headquartered in Bethlehem, Pennsylvania, Particle Sciences is a contract development and manufacturing organization (CDMO) and a Lubrizol LifeSciences company.
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 customised solubility software based on Hansen solubility parameters, Particle Sciences was able to achieve high levels of solubilised diazepam using a benign vehicle that is compatible with nasal delivery.
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.”
The NDA for VALTOCO is a 505(b)(2) filing utilising 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.
"The resulting absolute bioavailability of the VALTOCO intranasal formulation was 96% of intravenous diazepam in a Phase 1 cross-over trial of healthy volunteers," the company said in a statement.
Craig Chambliss, President and CEO of Neurelis, commented: “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.”
There are over 3.4 million people with epilepsy in the United States with approximately 200,000 new patients diagnosed each year. Despite the availability of chronic, daily oral medications to control epilepsy, a significant number of these patients continue to experience seizures. Of these uncontrolled patients, about 170,000 are at risk for cluster or acute repetitive seizures.
Particle Sciences will be exhibiting at this year’s American Association of Pharmaceutical Scientists (AAPS) PharmSci 360. The event takes place on 4-7 November at the Walter E. Washington Convention Centre, in the US.