LTR Pharma’s pivotal trial shows SPONTAN outperforms oral ED tablets. Pic: Getty images
Health & Biotech
Special Report: LTR Pharma’s pivotal trial for its novel intranasal formulation SPONTAN has demonstrated it outperforms traditional oral erectile dysfunction medications with faster onset, providing patients with greater spontaneity in their intimate relationships along with greater convenience.
LTR Pharma (ASX:LTP) has announced completion of the data evaluation phase of its pivotal clinical study assessing the pharmacokinetics and safety profile of SPONTAN, its novel intranasal formulation of vardenafil for ED.
Key results from the randomised, open-label, cross-over study demonstrate that SPONTAN Nasal Spray (5mg vardenafil) achieved a significantly faster time to maximum plasma concentration (Tmax) compared to the oral tablet (10mg vardenafil).
LTP said SPONTAN reached a mean Tmax of 12 minutes, compared to 56 minutes for the oral tablet, showing a 470% faster absorption.
LTP said the rapid onset provided patients with greater spontaneity in their intimate relationships and convenience compared to traditional oral ED medications.
The study involved 18 healthy adult males under fasting conditions, employing a cross-over design to compare the pharmacokinetics of SPONTAN nasal spray and vardenafil oral tablets.
Blood samples were collected at multiple time points over 24 hours to assess vardenafil concentrations.
The secondary endpoint evaluated the safety and tolerability of SPONTAN compared to the oral formulation.
Despite its lower 5mg dose, LTP said the SPONTAN nasal spray showed 111.8% dose-normalised bioavailability relative to the oral tablet.
Additionally, SPONTAN’s maximum plasma concentration (Cmax) was higher, achieving 155.6% of the oral tablet’s Cmax.
The half-life (t½) of vardenafil was similar for both formulations, with SPONTAN showing a mean half-life of 4.15 hours compared to 4.23 hours for the oral tablet.
SPONTAN was well-tolerated, with no serious adverse events (SAEs) reported.
All treatment-emergent adverse events (TEAEs) were mild to moderate and transient.
LTP said SPONTAN’s overall safety profile aligns with the known safety profile of vardenafil.
LTP said the data would enhance LTR Pharma’s ongoing global partnering and licensing discussions.
Additionally, it would support engagement with key regulatory bodies, including the US Food and Drug Administration and Australia’s Therapeutic Goods Administration.
LTP chief medical officer Professor Geoffrey Strange said the results were highly encouraging from a clinical perspective.
“The rapid onset of action and pharmacokinetic profile of SPONTAN have the potential to address unmet needs in erectile dysfunction treatment,” he said.
“The speed of absorption, combined with excellent bioavailability and safety, offers patients a more spontaneous and convenient therapeutic option.
“Positive anecdotal efficacy feedback from patients under the Special Access Scheme further supports our belief that SPONTAN represents a meaningful advancement in ED management.”
LTR Pharma’s Chairman, Lee Rodne, said the study results represented a significant milestone for the Company.
“SPONTAN’s pharmacokinetic profile and rapid onset of action highlight its potential to disrupt the global ED market,” he said.
“We are well-positioned to advance our commercialisation strategy, including progressing regulatory discussions and exploring strategic partnerships.
“This success reinforces our commitment to delivering innovative solutions that significantly improve patients’ lives while creating value for our shareholders.”
The LTP share price is up ~9% in morning trade.
This article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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