EVE Health Group (ASX: EVE) has met the necessary regulatory requirements, paving the way for Australian doctors to prescribe its lead products, Libbo and Dyspro. Libbo is designed to treat erectile dysfunction, while Dyspro aims to alleviate dysmenorrhoea. EVE Health Group is focused on developing, licensing, and marketing evidence-based solutions for unmet consumer needs with a specialisation in women’s health and wellness. Their wholly owned subsidiary, Nextract, is responsible for the market rollout of these new prescription drugs.
The approval falls under the Therapeutic Goods Administration’s (TGA) medicines access pathway, granting national prescriber coverage for both telehealth and in-clinic medical consultations. EVE anticipates the first prescriptions for Libbo and Dyspro will be issued before the end of the year. Following the initial launch in the Australian market, the company intends to apply to the Australian Register of Therapeutic Goods to support its international expansion plans.
EVE is proceeding with its Australian commercial rollout ahead of schedule, following the completion of final product manufacturing and packaging. The company is also in the process of appointing a national distribution partner, completing practitioner onboarding, and integrating prescription dispensing software. According to EVE chief operating officer Ben Rohr, meeting the regulatory prerequisites for launch is a significant achievement.
Libbo and Dyspro utilise established active pharmaceutical ingredients in fast-acting formats, addressing 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. Both are currently classified as unapproved medicines that can be legally prescribed in Australia through TGA-authorised frameworks for supply on prescription to patients.
