Nutra Pharma Corp. (NPHC) is fighting for Myasthenia Gravis Nutra Pharma Corp. (NPHC) is fighting for Myasthenia Gravis Sufferers with its Orphan Drug Application for RPI-78M
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
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