LTR Pharma surpasses 2,000 SPONTAN units dispensed under TGA Special Access Scheme
LTR Pharma (ASX:LTP) has announced that more than 2,000 bottles of SPONTAN®, its rapid-onset intranasal vardenafil spray, had been dispensed in Australia as at 20 October 2026. Dispensing took place under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS Category B) and Authorised Prescriber programs.
Key figures from the 21 October 2026 announcement include:
- 2,000+ bottles of SPONTAN dispensed in Australia
- 120+ clinicians who have prescribed SPONTAN on more than one occasion
- Dispensing across all six Australian states and the Australian Capital Territory
- First patient-specific ROXUS® prescriptions fulfilled in the US in October 2026
For investors, the figures point to real-world commercial traction in Australia, alongside the planned SPONTAN Phase III study and the company’s US programs.
Lee Rodne, Executive Chairman
“These figures demonstrate demand for an additional treatment option for men with erectile dysfunction, including those who have not responded adequately to oral therapies…”
Rodne also said the company’s focus is on expanding clinician awareness and building on this progress.
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Who is being prescribed SPONTAN
The Special Access Scheme (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. It applies where registered treatments are unsuitable, ineffective or unavailable.
By design, SAS prescribing is directed to patients whose clinical need has not been met by approved therapies. Uptake therefore signals demand among a higher-need group.
Real-world cohort of 147 men
SAS prescribing of SPONTAN has been concentrated in men with moderate or difficult-to-treat erectile dysfunction. This includes men who have not responded adequately to oral PDE5 inhibitors such as sildenafil (Viagra®) and tadalafil (Cialis®), and men with erectile dysfunction following prostate cancer surgery.
The announcement also summarised a real-world cohort study, previously reported in the company’s ASX announcement dated 11 August 2026.
The 147-patient real-world study also broke results down by patient motivation, with men seeking greater convenience and spontaneity reporting a 93% composite response rate.
| Measure | Result | Share of cohort |
|---|---|---|
| Men in cohort, all previously treated with oral PDE5 inhibitors | 147 | – |
| Sought SPONTAN after an inadequate response to oral therapy | 102 of 147 | Not stated |
| Had undergone prostatectomy | 87 of 147 | 59% |
| Reported improved erectile hardness and/or achieving penetration | 100 of 147 | 68% |
Intranasal speed and the path to Phase III and the US
Faster time to peak concentration
The final Phase II report (ASX announcement dated 1 October 2026) confirmed a median time to peak blood concentration (Tmax) of 10 minutes for SPONTAN 5 mg, compared with 60 minutes for oral vardenafil 20 mg (p<0.0001).
Tmax is the time a medicine takes to reach its highest concentration in the blood.
The final Phase II report also found no drug accumulation after five days of once-daily dosing, with pharmacokinetics comparable between men aged 65 and over and younger adults.
Real-world evidence feeding the pipeline
De-identified data collection from SAS prescribing is ongoing. Real-world experience in these higher-need patients continues to inform the planned SPONTAN Phase III study, the FDA 505(b)(2) programme and the US introduction of ROXUS, which is built on the same rapid-onset intranasal technology.
The first patient-specific ROXUS prescriptions were fulfilled in the United States in October 2026 (ASX announcement dated 6 October 2026).
The pathway described in the announcement runs as follows:
- Australian SAS use of SPONTAN
- Ongoing de-identified real-world data collection
- The planned SPONTAN Phase III study
- The FDA 505(b)(2) programme and the US introduction of ROXUS
The announcement does not disclose a Phase III timeline, trial size, FDA submission date or revenue figure.
What the milestone signals for LTR Pharma (ASX:LTP)
LTR Pharma describes itself as a commercial-stage pharmaceutical company with a proprietary intranasal drug-delivery platform. Its lead products are SPONTAN and ROXUS, while OROFLOW® is under development for the treatment of Oesophageal Motility Disorders.
Management’s stated focus is expanding clinician awareness and building on this progress. The announcement does not provide financial figures, so revenue, pricing and market share remain undisclosed.
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