Senetek Files PLA For INVICORP

Senetek has filed a Product Licensing Application with the DanishMedicines Agency for INVICORP, its injectable formulation of vasoactive intestinal polypeptide, in combination with phentolamine mesylate, for the treatment of moderate-to-severe, organic-based erectile dysfunction.

The PLA incorporates Phase III data from trials involving more than 700 males, and demonstrates that INVICORP was 81% effective in treating patients with the condition. In one study of 20 males with either chronic organic or psychogenic forms of erectile dysfunction, INVICORP was found to be 80% effective, while another study found a 70% efficacy rate in treatment-resistant patients. In trials, the most common adverse event was short-term facial flushing, reports the company. INVICORP is delivered using Senetek's autoinjector, which makes the injection process "exceptionally easy and unobtrusive to perform," the firm points out.

The company filed its first PLA in April this year with the UK Medicines Control Agency, and plans for more submissions in preparation for its pan-European approval, it says.