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news.Ampio Pharmaceuticals has entered into a contract with Syngene to manufacture Zertane-ED, a combination drug to treat both premature ejaculation (PE) and erectile dysfunction (ED).
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The positive pre-IND meeting with the FDA gave the company guidance for the two concurrent pivotal trials necessary for Zertane approval to treat PE in the US.
Ampio chief regulatory officer Vaughan Clift said 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.
"This definition fully complements and encompasses the clinical results from its successful Phase 3 studies of Zertane conducted in Europe which was reported in the prestigious journal European Urology," Clift added.
The agreement with Syngene will accelerate the initiation of the Phase III trial in South Korea.
By previous contractual agreement, Daewoong will finance and conduct the South Korean Phase III trial according to FDA standards/guidelines and the data generated will be used both for approval in South Korea and to support an FDA submission.
Ampio CEO Michael Macaluso said, "As a first step for the clinical study of Zertane-ED, Ampio entered into an agreement with Syngene (Bangalore, India) to begin manufacturing (in compliance with 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."