LTR Pharma passes 2000 SPONTAN dispensed units under TGA scheme

• More than 2000 bottles of LTR Pharma’s erectile dysfunction spray SPONTAN have been dispensed in Australia
• Treatment dispensed under TGA Special Access Scheme and Authorised Prescriber pathways
• Prescribing concentrated in those with inadequate response to oral PDE5 inhibitors, generating real-world evidence for planned Phase III study

Special Report: LTR Pharma has notched up a milestone for its erectile dysfunction (ED) spray SPONTAN with more than 2000 bottles dispensed in Australia as at October 20.

The units were dispensed under the Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS) and Authorised Prescriber pathways.

The spray reaches peak blood levels in around 10 minutes, compared with about an hour for the oral vardenafil tablet.

LTR Pharma (ASX:LTP) said more than 120 clinicians had now prescribed the company’s rapid-onset intranasal vardenafil spray on more than one occasion, with dispensing across all six Australian states and the Australian Capital Territory.

LTP said the numbers showed growing adoption among Australian clinicians treating men whose needs had not been adequately met by existing therapies including oral PDE5 therapies and injections.

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.

LTP said SAS prescribing of SPONTAN had been concentrated in those with moderate or difficult-to-treat ED.

The patients include those who have not responded adequately to oral PDE5 inhibitors such as sildenafil (Viagra) and tadalafil (Cialis) and those with erectile dysfunction following prostate cancer surgery.

In the real-world cohort study of 147 men, all participants had previously been treated with oral PDE5 inhibitors with 102 of the 147 seeking SPONTAN after an inadequate response to oral therapy, and 87 of the 147 (59%) having undergone prostatectomy.

Overall, 100 of the 147 men (68%) reported improved erectile hardness and/or achieving penetration.

A final Phase II report confirmed a median time to peak blood concentration (Tmax) of 10 minutes for SPONTAN 5mg compared with 60 minutes for oral vardenafil 20mg.

Building on progress in Australia

De-identified data collection from SAS prescribing is ongoing with real-world experience from the higher-need patients continuing to inform the planned SPONTAN Phase III study and its US FDA 505(b)(2) program.

The data is also instrumental to the introduction of its other ED treatment ROXUS in the US. ROXUS uses the same proprietary intranasal delivery platform as SPONTAN to deliver vardenafil as a rapid-onset nasal spray.

While SPONTAN is progressing through the FDA 505(b)(2) pathway, ROXUS is intended to reach patients sooner via the US 503A personalised medicine pathway.

The first patient-specific ROXUS prescriptions were fulfilled in the US in October.

LTR Pharma executive chairman Lee Rodne said surpassing 2000 bottles dispensed and reaching more than 120 prescribing clinicians were meaningful milestones for SPONTAN in Australia.

“These figures demonstrate demand for an additional treatment option for men with erectile dysfunction, including those who have not responded adequately to oral therapies.

“The experience gained through SAS use is informing our planned Phase III study and helping us support our US partners as they introduce ROXUS.

“Our focus is on expanding clinician awareness and building on this progress.”

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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