The FDA has accepted an orphan designation request for use of Truveta administered intranasally submitted by Axium Pharmaceuticals Inc.
The FDA has accepted an orphan designation request for the intranasal lorazepam (Truveta) administered intranasally in the Treatment of Lennox-Gastaut syndrome using the formulation that Axium Pharmaceuticals Inc. is developing.
Axium is a pharmaceutical company aimed at utilizing drug delivery innovations for developing improved novel formulations and alternative dosage forms of existing biologically active molecule. Its pharmaceutical products are developed using highly effective technologies and demonstrated usefulness in the improvement of bio-availability and biological action of incorporated molecules.
The company’s product candidates address various pharmaceutical markets, including neurological disorders, such as epilepsy and panic attacks, infectious diseases and diabetes. Axium is working closely with clinicians, patient advocate groups, and universities worldwide to identify existing health issues where Axium’s approach will be most beneficial for patient care.
Patent pending is Axium’s use of Truveta (lorazepam) administered intranasally, and also a new intranasal administration product that is accurate, reproducible and convenient for delivery of one or more predetermined unit doses of lorazepam in the form of a nasal spray delivery system.
The objective is to produce the relatively rapid onset of a therapeutic effect and the moderate duration of therapeutic activity, with minimal side effects and improved bio-availability.
Furthermore, the system’s delivery method is designed to be safe and easy, producing minimal physical discomfort and anxiety to the patient. The medication is delivered through a small, inexpensive, manually operated and disposable device, and will be prepared under aseptic conditions; no significant residue is left in the delivery device following administration.
Orphan drug designation will provide the following benefits, protocol assistance offered by FDA, tax credits of 50% of the clinical drug testing cost awarded upon approval, waiver of NDA/BLA application, waiver of NDA/BLA application fee this is a $2.2 million value and, and the designation would give Axium a seven-year market exclusivity for the sale of Truveta, among many other advantages.
Axium plans to soon be publicly traded.
(Source: PR Newswire)