EjectDelay’s active ingredient is a fast absorbing and vanishing gel formulation with the active drug benzocaine at 7.5% designed to reduce transfer to the partner.
A total of 50 patients will be enrolled in the 12-week, placebo-controlled, parallel, double-blind trial.
The trial’s primary endpoint is the evaluation of the Intra-Vaginal Ejaculatory Time (I-ELT) achieved by the product in patients with premature ejaculation in this Middle Eastern population and the effect of the product on the female partner.
The company said that Middle East and North Africa (MENA) market is a large market for these two indications (premature ejaculation and reduced penile sensitivity) and the two trials, once completed, will be the first controlled data to be reported in such a patient population.
Innovus Pharmaceuticals president and chief executive officer Bassam Damaj said to the company’s knowledge, EjectDelay is currently the only known benzocaine-based topical product clinically evaluated for premature ejaculation.
"We believe that this second study, if successful, will re-enforce our first clinical study, which has demonstrated the efficacy of the product in significantly delaying premature ejaculation and gives it the clinical edge to be recommended by many urologists for this indication," Damaj said.