EVE Health Group Secures Prescription Pathway for ED and Period Pain Treatments
EVE Health Group (ASX: EVE) has satisfied the regulatory requirements to enable Australian doctors to have prescription access to lead products Libbo (for erectile dyfunction) and Dyspro (for dysmenorrhoea).
The approval falls under the Therapeutic Goods Administration’s (TGA) medicines access pathway and provides national prescriber coverage for telehealth and in-clinic medical appointments.
EVE expects first prescriptions for Libbo and Dyspro to commence before year end and, following initial Australian market entry, the company will apply to the Australian Register of Therapeutic Goods to facilitate its international expansion plans.
Commercial Rollout
After the completion of final product manufacture and packaging, appointment of a national distribution partner, completion of practitioner onboarding and integration of prescription dispensing software, EVE will proceed with its Australian commercial rollout ahead of schedule.
“Meeting the regulatory prerequisites for launch is a major achievement and clears the way for Libbo and Dyspro to become available to patients in Australia,” EVE chief operating officer Ben Rohr said.
“This milestone reflects the quality of our team, the strength of our development and regulatory strategy and our commitment to bringing innovative, fast-acting solutions to market.”
EVE will continue stability testing with the aim of providing further validation for broader regulatory submissions including future application for TGA review for export markets.
Fast-Acting Formats
Libbo and Dyspro incorporate established active pharmaceutical ingredients into in fast-acting formats to target significant unmet needs in men’s and women’s health.
Libbo is an oral soluble film containing tadalafil, while Dyspro is a cannabinoid-based pastille formulation, with both currently classified as unapproved medicines that can be legally prescribed in Australia through TGA-authorised frameworks for supply on prescription to patients.
EVE’s wholly owned subsidiary Nextract signed an agreement with TeleDocs Clinic & Consulting in June for the online prescription and promotion of the two products.
The two-year agreement sees TeleDocs become the first online clinic and telehealth provider authorised to prescribe the products to patients across Australia.