Innovus Pharma Announces Initiation of a Clinical Study to Evaluate the Tolerance and the Effect of Musclin™ on Muscle Health in Adults in the United States
Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women's health and respiratory diseases, today announced the enrollment of the first participant in the clinical study to evaluate the effect and tolerance of Musclin™ dietary supplement. The study is being conducted at a single site in the United States and is expected to enroll up to 20 healthy subjects.
The study is designed as an open-label, uncontrolled, ascending dose study. Eligible participants will receive a daily dose of two capsules of Musclin™, containing thymol as a dietary supplement, for thirty days followed by an increase to four capsules of Musclin™ for an additional thirty days. The primary aim of the study is to evaluate the tolerance of individuals to Musclin™ over the course of the study period. In addition to evaluating tolerability of Musclin™, the study will observe the effect of Musclin™ in the measurements of creatinine kinase and myostatin levels which are signs of muscle breakdown, as well as additional assessments including self-reported changes in energy and stamina levels. Data from this trial is expected in the first half of 2019 following full enrollment and after all participants have completed their last dose.
“This study represents part of Innovus Pharma's strategy to leverage cutting-edge technologies that have been developed by pioneers in the field of muscle health and introduce clinically-tested and proven products to consumers,” said Bassam Damaj, the President and Chief Executive Officer of Innovus Pharma. “As a result of its unique mechanism of action on muscle fibers, we believe Musclin™ is one of the few products targeting the muscle fibers specifically and not the whole body protein synthesis pathways. We are hoping results from this study and potentially others to come will help to support individuals who want to maintain optimal muscle health as they age or suffer from muscle weaknesses,” he continued.
Musclin™ is a patent-pending dietary supplement containing thymol and BioPerine® intended to support muscle mass, muscle recovery time, and enhance endurance levels in adults.
Thymol, a phenol obtained from thyme oil, is generally recognized by the FDA to be a safe (“GRAS”) food ingredient and food additive shown to increase the size of muscle fibers. In vivo, results have suggested thymol improves exercise capacity and supports increased muscle mass. BioPerine® is a clinically studied, patented extract obtained from black pepper fruits (piper nigrum) used as a bioavailability enhancer in dietary supplements and recognized as GRAS by an independent expert panel. BioPerine® is also commercially available as a stand-alone dietary supplement.
More information about the current clinical trial can be found at https://clinicaltrials.gov/ct2/show/NCT03767504?term=musclin&rank=1 (NCT03767504).
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging OTC consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve men’s and women’s health and vitality and respiratory diseases. Innovus Pharma delivers innovative and uniquely presented and packaged health solutions through its (a) OTC medicines and consumer and health products, which we market directly; (b) commercial partners to primary care physicians, urologists, gynecologists and therapists; and (c) directly to consumers through our on-line channels, retailers and wholesalers. The Company is dedicated to being a leader in developing and marketing new OTC and branded Abbreviated New Drug Application (“ANDA”) products. The Company is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC.
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Innovus Pharma's Forward-Looking Safe Harbor:
Statements under the Private Securities Litigation Reform Act, as amended: With the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, projected revenues from the future sale of its Musclin™ product among others, estimated market for its products, and statements about achieving its other development, growth, commercialization, financial and staffing objectives. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent filing on Form S-1, annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
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