Ampio Pharmaceuticals, Inc.,  a biopharmaceutical company develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction, has initiated the development plan for a combination product to treat both premature ejaculation (PE) and erectile dysfunction (ED).

The positive pre-IND meeting was conducted in last month with the US FDA gave the company clear guidance for the two concurrent pivotal trials necessary for approval of Zertane to treat PE in the USA.

“Contrary to rumours that the US FDA did not recognize PE as a treatable ailment, the FDA has expressly adopted the definition of PE as a disease condition, using the definition of Premature Ejaculation provided by the International Society for Sexual Medicine (ISSM) Ad Hoc Committee (i.e., premature ejaculation is characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.) This definition fully complements and encompasses the clinical results from its successful phase III studies of Zertane conducted in Europe which was reported in the prestigious journal European Urology,” said Vaughan Clift, MD, Ampio's chief regulatory officer.

Michael Macaluso, Ampio's CEO added, “The clear clinical path for Zertane provided by the FDA, and the reasonable costs to complete these PE trials, allows Ampio to present potential distribution partners a portfolio of sexual dysfunction drugs that treat both PE and the PE/ED combination worldwide. Ampio was recently awarded multiple patents worldwide for combinations of Zertane with any PDE5 inhibitors and for reduction of side effects of Tramadol. These recently awarded patents will benefit from a full patent life and are important for negotiations with potential partners whose PDE5 inhibitors patent protection has expired or are about to expire which could be greatly extended by Ampio's patents.”

Macaluso continued, “As a first step for the clinical study of Zertane-ED, Ampio entered into an agreement with Syngene (Bengaluru, India) to begin manufacturing (in compliance with US FDA standards) the combo product for the conduct of a phase III trial for these co-morbid conditions in South Korea by our partner Daewoong Co. Ltd. By previous contractual agreement Daewoong will finance and conduct the South Korean phase III trial according to US FDA standards/guidelines and the data generated will be used both for approval in South Korea and to support a US FDA submission. This agreement with Syngene will accelerate the initiation of the phase III trial in South Korea.”

Zertane is a repurposed oral drug to treat premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. The active ingredient in Zertane has multiple mechanisms of actions that can delay ejaculation. This drug also has an excellent safety record established during 30 years of human use for other medical indications. These unique pharmaceutical qualities, exceptional human safety record, and a distinctive non-standard dosage not available in generic form, differentiate Zertane from other treatments for premature ejaculation. Zertane is taken as needed before sexual activity, and is not required on a daily basis.

Zertane-ED addresses a significant clinical need as up to 30 per cent of males treated for PE also suffer from ED and there are currently no therapies available for the men who experience both. Nearly all pharmaceutical companies, currently providing PDE5 inhibitor drugs to treat only ED are facing near term expiration of their patent protection and may find our combination drug to be an attractive means of significantly extending and upgrading their franchise in this large and rapidly growing clinical field.

Syngene, a Bengaluru-based internationally reputed contract research and manufacturing organization with multidisciplinary skills in chemistry and biology services. From early stage discovery and process development through to cGMP manufacturing, Syngene provides customized services to pharmaceutical and biotechnology majors, on a strong platform of confidentiality and intellectual property protection.