Innovus Pharmaceuticals, Inc. (Innovus Pharma), an emerging commercial stage pharmaceutical company, has initiated a pre-clinical and clinical programme 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 US 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 US 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; and (4) 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.
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.
Headquartered in San Diego, Innovus Pharma is an emerging commercial stage pharmaceutical company delivering over-the-counter medicines and consumer care products for men's and women's health and respiratory diseases.
