Ampio Pharmaceuticals Inc., a company that discovers and develops new uses for previously approved drugs and new molecular entities (NMEs), announced that it has received notification of allowance of its two patent applications on Zertane combinations with erectile dysfunction (ED) drugs in Canada. This allowance includes claims directed to the use of Zertane with a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors commonly used for the treatment of ED to address concurrent premature ejaculation (PE) and ED. The allowed claims also include composition of matter claims, such as claims directed to a pharmaceutical composition or a kit containing Zertane and a PDE5 inhibitor. Similar patent applications are being prosecuted worldwide.

It has been reported that ED and PE can co-exist in up to 30 per cent of patients. There may be patients with ED who are effectively treated with phosphodiesterase type 5 inhibitors but who may have PE. The patented combination of PE and ED drugs addresses this substantial group of patients.

“This first allowance of these two patents in Canada is an important milestone in Ampio's strategy to continue the development of its sexual dysfunction portfolio by first obtaining strong intellectual property protection,” said Don Wingerter Ampio's CEO. “We are very excited by this development as we anticipate it will help increase our growing out-licensing activity for this product line,” continued Don Wingerter.

The active ingredient in Zertane is a drug that was approved for marketing as a non-controlled analgesic in 1995. In two phase III clinical trials, Zertane has proven to be an effective oral medication to treat PE in men. Premature ejaculation is the most common form of male sexual dysfunction (four times the number with ED) with an estimated 23 per cent of males suffering from this condition. The impact on the quality of life for these men and their partners can be profound. Behavioural therapy is the current standard of care for treatment of PE.