The FDA Has Accepted an Orphan Designation Request for Use of Truveta Administered Intranasally Submitted by Axium Pharmaceuticals Inc.
PRNewswire: July 11, 2017 – HIGH POINT, NC, U.S.A. – Axium Pharmaceuticals Inc. (www.axium-pharma.com) is a pharmaceutical company aimed at utilizing drug delivery innovations for developing improved novel formulations and alternative dosage forms of existing biologically active molecules.
Axium is patent pending not only on the use of Truveta (lorazepam) administered intranasally but also a new intranasal administration product that is highly accurate, reproducible, and convenient for delivery of one or more predetermined unit doses of lorazepam in the form of a nasal spray delivery system. Furthermore, the system’s delivery method is designed to be safe and easy, producing minimal physical discomfort and anxiety to the patient.
Subveta oral spray for transmucosal delivery is based on our waterless self-nano emulsifying formula, which is designed to prevent precipitation of the active ingredient after contact with saliva. We believe the spray provides fast onset of action and is designed to optimize drug absorption through the oral mucosa. Because the drug enters the blood stream directly, it avoids the first pass metabolism in liver and is efficiently and quickly delivered to the brain.
Axium’s pharmaceutical products are developed using highly effective technologies and demonstrated usefulness in the improvement of bioavailability 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.
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 bioavailability.
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.
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 is developing.
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 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. Keep checking the website for updates. www.axium-pharma.com.
