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Innovus Files EjectDelay in Canada

Topical PE treatment looking for OTC approval

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Innovus Pharmaceuticals has filed a 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% strength in a two-ounce over-the-counter gel and will not require a prescription. The review process is approximately four months in Canada; assuming that no additional information is requested by Health Canada, approval should be coming soon.

Innovus 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.

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