Nutra Pharma, a US-based biotechnology a company specializing in the acquisition, licensing, and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune, and infectious diseases, recently announced that it has filed an application with the US Food and Drug Administration (FDA) for orphan drug status for its investigational drug RPI-78M as a treatment for pediatric multiple sclerosis (MS).
The company markets Nyloxin and Pet Pain-Away in the over-the-counter (OTC) pain management market, and also develops treatments for multiple sclerosis (MS), HIV, adrenomyeloneuropathy (AMN) and general pain.
If the orphan drug designation is granted to RPI-78M, it would provide the company with a seven-year period of market exclusivity in the US upon receiving FDA approval.
The FDA Orphan Drug Designation program provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
In the US, it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity periods intended to encourage the development of drugs, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees, which can offer savings of us to $2.5 million.
Nutra Pharma chairman and CEO Rik Deitsch said in a recent news release: “In May, we announced that we had engaged consultants to prepare several FDA applications for us as we start to re-engage our clinical platform. We have worked hard over the past year to restructure our Company, introduce a unique and effective OTC pet pain product, and now we are getting back to our roots as a biotechnology company. We have a broad product platform that consists of therapies for auto-immune diseases, viral diseases and neurological conditions.”
As for future goals of the company, Deitsch added: “Our goal now is to get our drug products through the approval process and into the market. It is very exciting that we are starting with this application that has the potential to help children suffering from MS.”
According to Nutra Pharma, venoms are an effective source of molecular tools that are able to improve the cell function understanding. The company also mentioned that the approval of some neurotoxins as human treatments has provided new opportunities for the treatment of MS.
RPI-78M induces gamma-interferon and interleukin-27 (IL-27). IL-27 is a recently discovered and important anti-inflammatory regulator in cells of the immune system. The drug was derived from a cobra venom extract and works as a nicotinic acetylcholine receptor antagonist. The drug has been found to have low toxicity with a very large therapeutic window. RPI-78M is to able Improve quality of fife, reduces chronic fatigue, improve walking ability and strength.