
EVE Health Group's pilot study for Libbo vardenafil oral soluble film for ED is underway. Results expected by end-September. CEO Rohr calls it a key milestone toward commercialisation.
EVE Health Group has started a pilot clinical study for its vardenafil oral soluble film Libbo, a treatment for erectile dysfunction. The study compares the pharmacokinetic profile of a 10 milligram Libbo dose against an Australian-registered reference vardenafil tablet under fasted conditions in healthy male subjects, EVE Health said.
This is the first clinical step in the planned bioequivalence development program for Libbo, a key requirement for regulatory registration. Libbo is a rapidly dissolving oral film designed as a discreet alternative to conventional tablets.
Subject recruitment and study activities are expected over the coming weeks, with results anticipated before the end of September.
EVE chief executive officer Ben Rohr called the pilot study a key milestone in Libbo's development.
Rohr was appointed CEO in April after serving as chief operating officer, during which he was instrumental in the company's operational and commercial progress. He has also been closely involved in positioning Libbo and Dyspro, a treatment for dysmenorrhea and endometriosis, for regulatory progression and market rollout.
EVE is also developing a reformulated version of the short-acting selective serotonin reuptake inhibitor dapoxetine to treat premature ejaculation, offering improved delivery characteristics. It has designed a dual-acting spray formulation combining vardenafil and dapoxetine for patients experiencing both ED and premature ejaculation, which frequently occur together.
In October, the company raised $1.1 million from sophisticated and professional investors to accelerate the commercial rollout of Libbo and Dyspro.
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