Innovus Pharmaceuticals, Inc., an emerging pharmaceuticals company, has filed its Product License Application with Health Canada to market its premature ejaculation topical treatment EjectDelay. EjectDelay has the active drug Benzocaine and works by blocking the sodium channels of the nerves and therefore temporarily desensitizing the glans of the penis allowing longer ejaculatory time.
If accepted by Health Canada, EjectDelay will be available as a 7.5 per cent strength in 2oz over-the-counter gel and will not require a prescription. The product is not expected to be reimbursed by the Canadian government, therefore, the Company will be able to set the retail price through its potential commercial partners.
The approval process is approximately four months in Canada, assuming that no additional information is requested by Health Canada.
"If approved by Health Canada for commercialization, Canada would be the second country where the drug is approved and is yet another milestone for the Company," said Dr Bassam Damaj, president and chief executive officer of Innovus Pharma. "Our goal to make the product available on a worldwide basis," continued Dr Damaj.
In addition, the company is in the process of getting regulatory guidance from the relevant health authorities in Europe, the Middle East, and Latin America in order to file for market authorization for the product in these territories.
EjectDelay is an over-the-counter (OTC) US Food and Drug Administration compliant proprietary topical treatment containing the drug benzocaine and indicated for delay of premature ejaculation. The drug typically works within minutes of application to the glans of the penis. In clinical trials, the application of benzocaine has been shown to delay premature ejaculation by several minutes.
Premature ejaculation (PE) is the most common sexual dysfunction reported by men but is still under-diagnosed and under-treated. PE can happen at any age and its prevalence is consistent across all ages. In an article in The Journal of Sexual Medicine in 2007 Sex Med 2007, D L Patrick, D Rowland and M Rothman state, "Global studies consistently report that 20-30 per cent of men experience PE worldwide. This means that PE is experienced at similar rates across the globe."
Innovus Pharma, is an emerging pharmaceuticals company that delivers innovative and uniquely presented and packaged health solutions through its over-the-counter medicines and consumer and health products.