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 pain.
The designation of RPI-78M as an orphan drug would provide the company with a seven-year period of market exclusivity in the US upon approval of the drug.
The orphan drug status also provides tax credits for clinical research costs, the ability to apply for grant funding, clinical trial design assistance, assistance from the FDA in the drug development process and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees which could be in excess of $2.5m.
Nutra Pharma chairman and CEO Rik Deitsch said: "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.
"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."
The company said that venoms have proven to be a potent source of molecular tools which have greatly improved the understanding of cell function and the approval of several neurotoxins as human therapeutics has unveiled new opportunities for the treatment of disease.
Originally, RPI-78M was derived from an extract of cobra venom and is an antagonist of the nicotinic acetylcholine receptor, and it has a low toxicity with a very large therapeutic window.