Innovus Pharmaceuticals, Inc. announced that its partner Khandelwal Laboratories received the approval of the product licenses for Zestra®, Zestra Glide®, EjectDelay®, and Sensum+® from the Indian FDA, The Drugs Controller General (India), and the Directorate General of Health Services to commercialize the products in India.
“We are thrilled to have received the approval to commercialize our products from the Indian FDA in a very short time due to the strength of the dossier and the clinical trials. India is our seventh country where we have our products approved and we look forward to start the commercial launch by our partner Khandelwal Labs in the very near future,” said Dr. Bassam Damaj, President and CEO of Innovus Pharmaceuticals, Inc.
On September 10, 2015 Innovus Pharma entered into an exclusive marketing and distribution agreement with Khandelwal Laboratories based in India (“KLab”) under which Innovus Pharma has granted to KLab an exclusive ten-year license and distribution rights to market and sell Innovus Pharma’s products. These products include Zestra® to increase Female Sexual Arousal and Desire and Satisfaction, EjectDelay® for treating premature ejaculation, Sensum+® to increase penile sensitivity and Zestra Glide®, the high-viscosity water-based lubricant. If KLabs exceeds its minimum yearly orders, the agreement has two five-year term extensions. Under the agreement, the minimum orders for the first term of the agreement are over two million and six hundred thousand ($2.6M) US dollars annually.
About Zestra® and Female Sexual Interest/Arousal Disorder (FSI/AD)
Zestra® is a patented blend of natural oils clinically-proven in double-blind placebo-controlled clinical trials in 276 women to increase in a statistical significant manner the arousal, desire and sexual satisfaction in FSI/AD women. Zestra® is the first Natural Health Product (NHP) to receive approval for the indication of FSI/AD in Canada as an NHP. To date, the Company believes that no product has been approved to treat FSI/AD, a persistent or recurring inability to attain or maintain adequate sexual excitement until the completion of a sexual activity. The diagnosis can also refer to an inadequate lubrication-swelling response normally present during arousal and sexual activity causing personal distress. Published papers on the FSI/AD market size estimate it to be equal or larger than the market for erectile dysfunction in males, and possibly larger. Zestra® is currently available in the United States, Canada and Morocco.
About EjectDelay® and Premature Ejaculation
EjectDelay® is an over-the-counter (OTC) U.S. Food and Drug Administration and Health Canada compliant proprietary topical treatment containing thedrug benzocaine and indicated for treatment 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 stated, “Global studies consistently report that 20-30 percent of men experience PE worldwide.”
About Sensum+® and Reduced Penile Sensitivity (RPS)
Sensum+® is a patented blend of essential oils and natural botanicals including rose oil, sweet almond oil, cinnamon bark oil, and other extracts. The main ingredient of Sensum+® (cinnamon oil) works by activating the Transient Receptor Potential A1 (TRPA-1) channels responsible for the heat and cold sensation of the skin and results in an increase of sensation that current users welcome and appreciate. The safety and efficacy of Sensum+® was evaluated in 2 post marketing survey studies in circumcised and non-circumcised men. A total of 382 men used Sensum+® twice daily for fourteen consecutive days followed by once daily for 8 weeks and as needed thereafter.
Reduced penile sensitivity is a major problem associated with many diseases such as hernia surgery, the use of anti-depressants, circumcision, multiple sclerosis and others. There are no approved products to treat RPS.
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Filed Under: Drug Discovery
