Nutra Pharma Announces the Submission of Their First Orphan Drug Application to the US Food and Drug
July 15, 2015
July 15, 2015 -- Coral Springs, Florida -- Nutra Pharma Corporation (OTC: NPHC), a biotechnology company marketing Nyloxin® and Pet Pain-Away in the over-the-counter (OTC) pain management market, and which is also developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that they have filed an application with the FDA for orphan drug status of the Company's RPI-78M drug candidate for the treatment of Multiple Sclerosis in children.
“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," stated Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. "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,” he continued. “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," he concluded.
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The Orphan Drug Act of 1983 is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as those affecting fewer than 200,000 Americans at any given time. The designation of RPI-78M as an Orphan Drug would provide Nutra Pharma with a 7-year period of market exclusivity in the U.S. upon approval of the drug, as well as 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 $2.5 million. The decision to proceed with an Orphan Drug Designation submission is part of Nutra Pharma’s plan to move forward with the preparation of an Investigative New Drug Application.
Venoms have proven to be a potent source of molecular tools which have greatly enhanced our understanding of cell function. The approval of several neurotoxins as human therapeutics has unveiled new opportunities for the treatment of disease. RPI-78M was originally derived from an extract of cobra venom and is an antagonist of the nicotinic acetylcholine receptor. The drug has a remarkably low toxicity with a very large therapeutic window. Scientific publications have demonstrated that native and modified neurotoxins can protect nerve cells from early cell death. Furthermore, it is expected that RPI-78M may be beneficial in neuromuscular disorders where the activity of nicotinic acetylcholine receptor has been compromised. The proprietary technology is covered by patents describing the application and use of RPI-78M in the treatment of autoimmune diseases.
About Nutra Pharma Corp.
Nutra Pharma Corporation operates as a biotechnology company specializing in the acquisition, licensing, and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune, and infectious diseases, including Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain. Additionally, the Company markets drug products for sale for the treatment of pain under the brand Nyloxin® and Pet Pain-Away.
For additional information about Nutra Pharma, visit:
http://www.NutraPharma.com or http://www.nyloxin.com http://www.petpainaway.com
This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The submission of an Orphan Drug application should not be construed as an indication in any way whatsoever of the future value of the Company’s common stock or its financial value. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.