Nutra Pharma Corp. (OTCQB: NPHC)
hasn’t forgotten about the sufferers of myasthenia gravis (MG). The Coral
Springs, Florida-based company announced in December 2015 that it had applied
for Orphan Status from the Food and Drug Administration (FDA) for its RPI-78M
treatment for MG. RPI-78M, described as modified a-cobra toxin in the FDA
Orphan Drug database, has already been granted Orphan Status for the treatment
of pediatric multiple sclerosis for sufferers up to the age of 16.
Under the Orphan Drug Act of 1983,
a drug to treat a ‘rare disease or condition’ can be granted special status
referred to as Orphan Designation or, alternatively, Orphan Status. A ‘rare
disease or condition’ is one that, generally, affects ‘less than 200,000
persons in the United States’ or ‘affects more than 200,000 in the United
States and for which there is no reasonable expectation that the cost of
developing and making available in the United States a drug for such disease or
condition will be recovered from sales in the United States… within 7 years’.
In addition, Orphan Status gives access to incentives that include 7-year
marketing exclusivity, tax credits (up to 50% of clinical development costs),
an exemption/waiver of application fees and general assistance from the Office of
Orphan Products Development (OOPD), an agency of the FDA. Although Orphan
Status for a drug is not a requirement, developers of Orphan Status drugs may
also be awarded grants under the Orphan Products Grants Program.
According to the U.S. National
Library of Medicine’s PubMed Health portal, ‘Myasthenia gravis is a rare
autoimmune condition in which antibodies produced by the immune system attack
the connection between nerves and muscles (the neuromuscular junction). Nerve
impulses become blocked, causing muscles to become weak and easily tired.
Symptoms fluctuate in severity. Acetylcholine is a chemical messenger that
carries signals between nerve and muscle. An enzyme called
acetyl-cholinesterase breaks down acetylcholine. Some drugs that are used to treat
myasthenia gravis act on acetyl-cholinesterase to stop the breakdown of
acetylcholine. These acetyl-cholinesterase inhibitors increase the amount of
acetylcholine available and so help muscle activation and contraction.’
Consequently, cholinesterase inhibitors enhance communication between muscles
and nerves and may improve muscle contraction and muscle strength.
With RPI-78M, Nutra Pharma is
taking a different approach. RPI-78M contains anti-cholinergic peptides that
recognize the same receptors as nicotine (acetylcholine receptors) but have the
opposite effect. In other words, an anti-cholinergic drug like RPI-78M has the
opposite pharmacological action to a cholinesterase inhibitor. An
anti-cholinergic works by blocking the action of the neurotransmitter
acetylcholine in the brain and so stops involuntary movements of the muscles
associated with these diseases.
Nutra Pharma is a
biopharmaceutical company engaged in the acquisition, licensing and marketing
of homeopathic treatments and ethical drugs for the management of pain,
neurological disorders, cancer, auto-immune and infectious diseases. The
company, through its subsidiaries, carries out basic drug discovery research
and clinical development and also seeks strategic licensing partnerships to
reduce the risks associated with the drug development process. Nutra Pharma’s
subsidiary, ReceptoPharm, is developing technologies for the production of
drugs for HIV and Multiple Sclerosis (MS). Another subsidiary, Designer
Diagnostics, is engaged in the research and development of diagnostic test kits
designed to be used for the rapid identification of infectious diseases such as
Tuberculosis (TB) and Mycobacterium avium-intracellulare (MAI). Nutra Pharma’s
clinical drug development costs are partially offset by the revenue from its
Nyloxin OTC line of products.
For more information on the
company, visit www.NutraPharma.com
About QualityStocks
QualityStocks is committed to connecting subscribers with
companies that have huge potential to succeed in the short and long-term
future. We offer several ways for investors to find, evaluate, and learn more
about investing in these companies.
The Quality Stocks Daily Blog http://blog.qualitystocks.net
The Quality Stocks Daily Videos http://videocharts.qualitystocks.net
The Quality Stocks “Ones to Watch” http://gotstocks.qualitystocks.net
Please see disclaimer on the QualityStocks website: http://disclaimer.qualitystocks.net
No comments:
Post a Comment