PLETHORA SOLUTIONS TO BEGIN PHASE III U.S. TRIAL OF INVICORP
Senetek announced that Plethora Solutions, Senetek's exclusive licensee for its patented erectile dysfunction drug Invicorp in North America, has said that, following positive discussions with the FDA, Plethora Solutions intends to initiate the final component of the clinical development program for Invicorp in the U.S. in the second quarter of this year.
The Phase III program, taking place in up to 30 sites in the U.S., is anticipated to take approximately 12 months to complete.
Plethora licensed the exclusive North American rights to Invicorp from Senetek last year. Invicorp is a patented injectable combination of phentolamine mesylate and vasoactive intestinal polypeptide. Clinical data indicate that the efficacy and local tolerability profile of Invicorp compare favorably with currently used injectable therapies.
The product has already received marketing authorization in Denmark, which has been chosen as the Reference Member State for the Mutual Recognition Procedure in Europe, as well as in the UK. The drug has been approved in New Zealand.
"The arrival of Invicorp into the U.S. market should make an invaluable addition to our therapeutic armamentarium for many men, in particular those individuals for whom phosphodiesterase inhibitors give an unsatisfactory response or are contraindicated and for those who like the quality and the speed of onset of an injectable," Tom Lue, president of the Sexual Medicine Society of North America, said.