Nutra Pharma Corp., a biotechnology company marketing Nyloxin® and Pet Pain-Away in the over-the-counter (OTC) pain management market, as well as developing treatments for multiple sclerosis (MS), human immunodeficiency virus (HIV), adrenomyeloneuropathy (AMN) and pain, announced today that it has applied for an Orphan Drug designation from the U.S.-FDA for the Company’s RPI-78M drug candidate for the treatment of myasthenia gravis (MG). In September 2015, Nutra Pharma was granted an Orphan Designation for this drug candidate for the treatment of pediatric MS.
“We have been clear over the last year that we would be moving our drug platforms forward,” stated Rik J Deitsch, chairman and CEO of Nutra Pharma. “This includes our work in pediatric multiple sclerosis, as well as additional potential Orphan Designations for our therapeutic pipeline. We expect to receive the Orphan Designation for MG. In the meantime, we will continue to work with our FDA consultants to prepare for an Investigative New Drug Application as we develop the clinical trial protocols for pediatric MS.”
For those unfamiliar with MG, it is a chronic autoimmune neuromuscular disease characterized by varying degrees of weakness of the skeletal (voluntary) muscles of the body. The name “myasthenia gravis” literally means “grave muscle weakness.” MG is known for causing muscle weakness that increases during periods of activity and improves after periods of rest. Certain muscles, such as those that control eye and eyelid movement, facial expression, chewing, talking and swallowing, are often, but not always, involved in the disorder. The muscles that control breathing and neck and limb movements may also be affected. RPI-78M is believed to be effective in the treatment of MG through the modulation of the immune system, preventing autoimmune effects.
By receiving Orphan Drug status, Nutra Pharma would benefit from a seven-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. It also allows the company to move forward with its preparation of an Investigative New Drug Application and proposal of clinical trials. 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.
Originally derived from an extract of cobra venom, RPI-78M is an antagonist of the nicotinic acetylcholine receptor. The drug has an unusually low toxicity with a very large therapeutic window. Scientific publications have shown that native and modified neurotoxins can protect nerve cells from early cell death. Also, 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.
For additional information about Nutra Pharma, visit www.NutraPharma.com
Let us hear your thoughts: Nutra Pharma Corp. Message Board
