Innovus Pharma (INNV) Targets Underserved Multi Billion Dollar FSI/AD Market
Published Monday, June 20, 2016 by Ryan Allway
Male sexual dysfunction has become a multi-billion-dollar market fueled by sales of erectile dysfunction drugs like Viagra and Cialis. In fact, Pfizer Inc.’s (NYSE: PFE) Viagra surpassed $1 billion in sales during its first year despite having lower than usual third-party coverage. The drug has consistently surpassed $1 billion per year in sales since its launch and even briefly reached above $2 billion mark back in 2012 despite growing competition.


Figure 1 – Pfizer’s Viagra Revenue – Source: Statista

But surprisingly, sexual dysfunction is much more prevalent among women than men (43% vs. 31%) with lack of interest cited as the most frequently reported female sexual complaint. The problem is that there are far fewer widely accepted treatments for the condition compared to the male equivalent drugs. Estrogen and androgen therapies are hit-or-miss in nature, while experimental drugs like Flibanserin and Tibolone have significant side effects.

In this article, we will take a look at Innovus Pharmaceuticals Inc. (OTCQB: INNV) and its clinically proven treatment for female sexual dysfunction, as well as its potential in an early-stage market that could be larger than the erectile dysfunction market.

Billion Dollar Problem

Female Sexual Interest Arousal Dysfunction – or FSI/AD – represents a sizable market that’s potentially larger than the multi-billion-dollar erectile dysfunction – or ED – marketplace. Community studies have shown that FSI/AD affects between 25% and 63% of women with an average prevalence of 43% compared to just 31% for ED’s prevalence in men. The Expert Review of Obstetrics & Gynecology published an extensive review of these statistics in a 2009 report.

Common FSI/AD symptoms reported include:
  • Unable to Achieve Orgasm – 22-28%
  • Pain During Sex – 8-21%
  • Sex Not Pleasurable – 17-27%

Despite the prevalence of these conditions, there are no FDA approved prescription medications in the market labeled for use in treating FSI/AD. The only existing treatments are used off-label and involve a range of potential adverse side effects, as well as the use of personal lubricants and devices that may or may not be effective.

Clinically Proven Solution

Innovus Pharmaceuticals’ Zestra® caters to a large and unmet medical market as a leading over-the-counter brand franchise for improving female arousal desire and sexual satisfaction. In two placebo-controlled, double-blinded U.S. clinical trials in 276 women, Zestra® was found to be effective in meeting both safety and efficacy end points that included FSFI and FSEP scores, as well as treatment satisfaction questionnaires and other surveys.


Figure 2 – Innovus Clinical Study Results – Source: Company

These studies showed a statistically significant increase in desire and arousal in women using Zestra® compared to placebo, as measured by FSFI and FSEP scores. Secondary endpoints also confirmed increases in treatment satisfaction, sex life satisfaction, and other scores of satisfactions. In fact, Zestra® users were six times more satisfied with their treatment compared to placebo and more than twice as sexually satisfied compared to the placebo.


Figure 3 – Innovus Secondary Endpoints – Source: Company

Zestra® also has a well-established safety profile with no series adverse events, no drug interactions (e.g. with birth control, anti-depressants, etc.), and no impact on hormones. In addition, the treatment’s ingredients are generally recognized as safe (GRAS).

Extensive Distribution & Growth

Innovus Pharmaceuticals’ markets Zestra® through its large and growing distribution network that includes top-tier pharmacies. In addition, the company’s distribution network covers a variety of big box retailers like Walmart, Target, and Sears, as well as a growing number of international locations across 60 countries. This network is being built upon over time to include more and more retail locations and distributors.

According to its recent investor presentation, the company has already signed more than $500 million in sales milestones and plans on reaching a positive cash flow this year thanks to a strong commercial revenue-generating product pipeline. Management plans to expand upon this growth in 2017 to become profitable on a net income basis and ultimately unlock significant value for shareholders by bringing new products to market.

Looking Ahead

Innovus Pharmaceuticals plans to capitalize on the enormous market for female sexual interest arousal dysfunction with a clinically proven product with widespread distribution. Investors may want to keep an eye on the stock over the coming quarters as it expands awareness of Zestra® and works to build out its other pipeline products. As it transitions to profitability, the company will likely attract the interest of a growing number of institutional investors.

For more information, visit the company’s website at

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