Innovus Pharma (INNV) Commences Vesele Combo Safety, Efficacy Program
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Innovus Pharmaceuticals, Inc. (OTC: INNV) announced the initiation of a pre-clinical and clinical program intended to evaluate the safety and efficacy of the combination of its supplement Vesele® for promoting sexual health with sildenafil indicated for treating erectile dysfunction. Sildenafil in the U.S. is sold under the name Viagra® by Pfizer, Inc. (“Pfizer”).
Vesele® is a proprietary oral formulation of L-Arginine and L-Citrulline with the natural absorption enhancer Bioperine®. Vesele® was formulated to increase blood flow and nitric oxide production.
As previously reported, the Company performed a U.S. human clinical survey to evaluate erectile dysfunction and sexual satisfaction in men using Vesele® twice daily for up to four months with the following favorable results:
1. 49.5% increase in erection hardness;2. 44.5% increase in erection maintenance;3. 34.6% increase in desire for sexual activity; and4. 34.1% increase in the ability to satisfy the partner.
“Due to the positive results obtained on the erection hardness and maintenance in the clinical use survey with Vesele® and the complimentary mechanism of action of Vesele® on nitric oxide and blood flow, we believe it is only natural to evaluate the effects of the combination of both products on erectile dysfunction endpoints,” said Innovus CEO Dr. Bassam Damaj.
The open label, single arm study is designed to assess the safety and effect of concomitant use of Vesele® and sildenafil in men diagnosed with erectile dysfunction. The treatment consists of oral administration of Vesele® twice daily (BID) for four weeks and sildenafil 100 mg taken concurrently once weekly. Safety will be evaluated by the number of subjects experiencing adverse events and changes in safety parameters that include physical examination, clinical lab tests, and concomitant medication usage. The IIEF (International Index of Erectile Function), a multi-dimensional, validated diagnostic tool will be used to assess erectile function and treatment outcomes.
About Vesele®Vesele® is a proprietary, novel oral dietary supplement to maximize nitric oxide’s beneficial effects on sexual function and brain health. Vesele® contains a patented formulation of L-Arginine and L-Citrulline, in combination with the natural absorption enhancer Bioperine®. For more information on Vesele® please visit www.myvesele.com.
Viagra® is a trademark owned by Pfizer.
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