EVE Health Group begins stability testing of oral treatments for ED and period pain

EVE Health Group (ASX: EVE) has commenced stability testing of its leading oral formulation products for treating erectile dysfunction (ED) and dysmenorrhoea (period pain).

Stability testing is mandatory under pharmaceutical product research guidelines to ensure new drugs maintain quality, safety and efficacy under various environmental conditions across their designated shelf life.

Testing examines physical, chemical and microbiological characteristics and is a necessary part of the initial product registration process.

TGA approval

Results from EVE’s testing will form a core component of the technical dossier the company plans to lodge with Australia’s Therapeutic Goods Administration (TGA).

EVE has previously completed sponsor and manufacturer registration with the TGA and views this as a key step in advancing its health and wellness strategy across regulated markets and expects approval before year end.

Analysts have valued the global ED and dysmenorrhoea markets at approximately US$5.3 billion and US$10.9b, respectively.

Unmet clinical needs

EVE chief operating officer Ben Rohr said the start of testing marked an important milestone in the development of the drugs to address unmet clinical needs.

“Stability testing is an important step in preparing these new medicines for commercialisation—it reflects the significant technical progress made by our team and keeps us firmly on schedule,” he said.

“We are focused on delivering new therapeutic options where existing solutions are either slow-acting or poorly tolerated.”

Nextract acquisition

Australian biotech company Nextract developed the treatments to deliver proven active pharmaceutical ingredients (APIs) in novel dissolvable formats for faster therapeutic onset.

EVE shareholders approved the $3 million acquisition of Nextract last week, a move EVE expects will enhance its technical capabilities across pharmaceutical formulation and solubility science in support of broader strategic initiatives.

Nextract reformulates known molecules into new delivery formats to develop faster-acting, easier-to-use formats for well-established APIs previously delivered as traditional oral tablets.

The company’s lead products are an oral, alcohol-free strip to treat ED and a natural, non-hormonal solution for dysmenorrhoea.