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
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