Acrux gains FDA clarity for female testosterone Phase III

FDA confirms pivotal trial requirements

The US FDA has given Acrux Limited (ASX:ACR) a defined route into Phase III for its Female Testosterone metered-dose transdermal spray, narrowing one of the biggest uncertainties around the company’s lead women’s health program.

Following formalisation of the minutes from an end-of-Phase II meeting, the regulator confirmed that two adequate and well-controlled 24-week trials should demonstrate reproducible efficacy in postmenopausal women with hypoactive sexual desire disorder, or HSDD. A further 28 weeks of data, bringing the total to 52 weeks, will be used to assess safety for chronic treatment.

The FDA said the trials do not need to be identical, giving Acrux some flexibility over design and timing. It also outlined alternative approaches for patient-reported outcome co-primary endpoints, allowing the company to select the measures it considers most appropriate for the program. The update follows the company’s earlier Phase II regulatory roadmap, which had set out plans for pivotal trials in the US and Australia.

Three-year exclusivity remains prospective

The FDA also confirmed that Acrux’s planned Phase III studies and new formulation meet the requirements for the company to apply for three years of data exclusivity when it submits its application. That protection is available for the first approval of an established active ingredient for a new indication when new clinical studies support the application.

That is a potentially important commercial advantage, but it is not yet an award of exclusivity. Acrux still needs to complete the required studies, make a submission and secure approval before the protection could have practical effect. The announcement does not provide a Phase III start date, trial budget or financing plan.

Safety study and FDA workshop shape development

The FDA treated the testosterone spray as a new formulation and said a chronic dermal and systemic safety study would be consistent with its guidelines. Acrux is finalising the protocol for that study alongside the Phase III trial designs.

The regulatory feedback arrived after a September FDA workshop on testosterone use in menopausal women. Acrux said the workshop highlighted the need for an FDA-approved, female-specific treatment, controlled dosing and testosterone exposure within the physiological range. Those themes align with the company’s stated positioning for a metered-dose transdermal product, although the next material test will be whether the final protocols can translate that regulatory clarity into successful recruitment and clinical results.