Nutra Pharma has completed submission of the final Nyloxin OTC and Nyloxin Rx packaging and labeling to the Food and Drug Administration (FDA). This registration is considered the final step required by the FDA to begin selling Nyloxin OTC and Nyloxin Rx in the United States for the treatment of chronic pain.
Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has successfully submitted the final packaging and labeling to the Food and Drug Administration (FDA) to begin selling Nyloxin OTC, an over-the-counter treatment for moderate to severe (Stage 2) chronic pain, and Nyloxin Rx, a prescription treatment for severe (Stage 3) chronic pain.
“Completing the FDA registration for Nyloxin OTC and Nyloxin Rx is an important and required step towards introducing our Nyloxin-branded pain relievers throughout domestic and international markets,” explained Rik J Deitsch, Chairman and CEO of Nutra Pharma. “With the FDA registration now completed, we plan to immediately move forward with our launch of Nyloxin Rx here in the United States, while we finalize our international drug registrations in Canada, Europe and South America for both our prescription and over-the-counter formulations,” he concluded.
The Company first introduced Nyloxin OTC in November as a treatment for moderate to severe (Stage 2) chronic pain. Nyloxin OTC is similar to the Company’s recently launched pain reliever, Cobroxin, and will be available internationally as an oral spray for treating lower back pain, migraines, neck aches, shoulder pain, cramps and neuralgia and as a topical gel for treating joint pain and pain associated with repetitive stress and arthritis.
Additionally, the Company introduced Nyloxin Rx in October as a prescription treatment for severe (Stage 3) chronic pain. Unlike Stage 2 pain, which interferes with both work and sleep, Nyloxin Rx is aimed at treating the most severe pain that inhibits one’s ability to fully function.
Both Nyloxin OTC and Nyloxin Rx are produced by Nutra Pharma’s wholly-owned drug discovery subsidiary, ReceptoPharm, and do not rely on the use of opioids or acetaminophen for their pain relieving action.
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 Company's business is subject to various risks, which are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"). Completing the FDA registration for Nyloxin OTC and Nyloxin Rx should not be construed as an indication in any way whatsoever of the value of the Company or its common stock. 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.