LTR Pharma Limited (ASX:LTP) has announced that more than 2,000 bottles of SPONTAN®, our rapid-onset intranasal vardenafil spray, have been dispensed in Australia under the Therapeutic Goods Administration (TGA) Special Access Scheme.
Highlights:
- More than 2,000 bottles of SPONTAN® dispensed in Australia under the TGA Special Access Scheme and Authorised Prescriber pathways
- Over 120 established prescribers of SPONTAN, with dispensing across all six Australian states and the Australian Capital Territory
- Prescribing concentrated in men with an inadequate response to oral PDE5 inhibitors, generating real-world evidence for the planned SPONTAN Phase III study
- Australian prescriber and patient experience informing the U.S. introduction of ROXUS®, built on the same rapid-onset intranasal technology, following fulfilment of the first U.S. prescriptions in October 2026
Special Access Scheme
The SAS allows a clinician to prescribe a medicine that is not yet registered in Australia for an individual patient, on a case-by-case basis, where registered treatments are unsuitable, ineffective or unavailable.