SPONTAN Phase 1 Study Accepted for WMSM 2026 Podium
Released
Released
Announcement PDF
1800 519 711 | ltrpharma.com | investors@ltrpharma.com
LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
Phase 1 SPONTAN®
Nasal Spray Study Accepted for Podium
Presentation at World Meeting on Sexual Medicine 2026
08 January 2026
Highlights
Independent Phase 1 data supporting rapid absorption of SPONTAN®
validated by podium acceptance at
a leading global scientific congress
SPONTAN®
nasal spray achieved notably shorter time to peak concentration (Tmax) compared to oral
vardenafil tablets
Higher dose-normalised bioavailability observed with SPONTAN®
despite a lower administered dose, with
a well-tolerated safety profile
LTR Pharma Limited (ASX:LTP) (“LTR Pharma” or “the Company”) is pleased to announce that an abstract relating
to its Phase 1 clinical study of SPONTAN®
has been accepted for podium (oral) presentation at the World Meeting
on Sexual Medicine (WMSM) 2026, organised by the International Society of Sexual Medicine (ISSM).
The abstract, entitled “Evaluation of Pharmacokinetics Profile and Safety Outcomes Comparing Nasal SPONTAN
versus Oral Vardenafil Formulations”, will be presented by Professor Eric Chung and reports results from a Phase
1, open-label, randomised, single-dose crossover study conducted in healthy adult males.
The study compared SPONTAN nasal spray (vardenafil 5 mg) with oral vardenafil tablets (10 mg). It assessed key
pharmacokinetic parameters, including time to maximum plasma concentration (Tmax), maximum concentration
(Cmax), overall drug exposure (AUC), half-life, and safety outcomes.
The study demonstrated that SPONTAN nasal spray achieved faster drug absorption, with a notably shorter
median Tmax compared to the oral tablet. When adjusted for dose, SPONTAN demonstrated higher dose-
normalised bioavailability despite the lower administered dose. Both formulations were well tolerated, with
predominantly mild, transient adverse events.
Based on the study findings, the investigators concluded that SPONTAN nasal spray demonstrated faster drug
absorption and higher dose-normalised bioavailability compared to the oral tablet, with a notably shorter Tmax.
This shorter Tmax is expected to translate into a more rapid onset of action with a favourable safety profile,
potentially offering greater treatment flexibility for patients with erectile dysfunction who seek immediate
treatment and sexual spontaneity.
LTR Pharma Scientific Advisory Board member, Professor Eric Chung, said:
“The acceptance of this study for an oral podium presentation at WMSM/ESSM 2026 in Porto reflects strong
international scientific interest in the SPONTAN nasal spray technology. The pharmacokinetic profile observed
highlights the potential advantages of intranasal delivery compared to oral tablets, particularly in terms of clinical
safety and speed of drug absorption, which is highly critical to men suffering from erectile dysfunction.”
1800 519 711 | ltrpharma.com | investors@ltrpharma.com
LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
The podium presentation represents international scientific recognition of the SPONTAN Phase 1 study and
provides an opportunity to share the findings with the global sexual medicine community. No new clinical data is
being disclosed in this announcement.
LTR Pharma notes that the study was industry-initiated and sponsored by the Company, with execution and
analysis conducted by independent investigators.
- ENDS –
This announcement has been approved by the Board of Directors.
About LTR Pharma
LTR Pharma is a commercial-stage pharmaceutical company delivering innovative therapies to address significant
unmet medical needs through its proprietary intranasal drug-delivery platform. The Company has successfully
commercialised its rapid-acting treatment technology in Australia and is expanding access whilst advancing
regulatory pathways in the US and other key markets.
LTR’s lead products, SPONTAN®
and ROXUS®
, are fast-acting intranasal sprays for the treatment of erectile
dysfunction, enabling onset of action in 10 minutes or less. Building on this proven technology, the Company is
now advancing OROFLOW®
, a novel intranasal spray under development for the treatment of Oesophageal
Motility Disorders (OMD) – a debilitating group of conditions affecting swallowing function.
Through strategic partnerships, LTR Pharma is expanding its pipeline and global footprint to deliver differentiated,
patient-centric treatments that enhance quality of life.
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For further information please contact:
Media enquiries Investor enquiries
Haley Chartres Peter McLennan
haley@hck.digital investors@ltrpharma.com
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