Patients uplifted by LTR Pharma’s ED treatment Spontan under TGA scheme

LTR Pharma’s fast-acting erectile dysfunction treatment Spontan has been given to first patients under TGA Special Access Scheme
Company has a key opinion leader strategy to introduce Spontan to market
LTR Pharma says its strategy will provide a platform to collect and share data at international conferences and in scientific publications

Special Report: The first patients have received LTR Pharma’s novel proprietary PDE5 nasal spray treatment for erectile dysfunction (ED) Spontan under Australia’s Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS).

Clinical stage biotech LTR Pharma (ASX:LTP) says in a major milestone patients were prescribed Spontan by the Restorative Sexual Health Clinic (RSHC), which provides evidence-based care to help individuals achieve optimal sexual function and improve intimate relationships.

The TGA’s SAS enables health practitioners to access unapproved therapeutic goods for individual patients, assessed on a case-by-case basis.

RSHC founder, nurse practitioner and sexologist Melissa Hadley Barrett, has extensive experience in primary care and is dedicated to offering evidence-based treatments to improve sexual health.

She is a sought-after speaker and educator for health professionals and community members for increasing knowledge and education around sexual health and has been published in international peer-reviewed journals.

Keeping up with, and surpassing, oral administration

In early June LTR Pharma reported positive results from primary and secondary clinical studies for Spontan, which is a fast-acting, on-demand nasal spray designed to treat ED.

Initial data showed that, despite a lower dose, the spray reached the same maximum concentration (Cmax) level as oral administration.

Volunteers experienced observable effects in as little as nine minutes, with an average of 12 minutes, compared to 56 minutes (Tmax) for oral treatment.

Conducted in Sydney with Southern Star Research and Scientia Clinical Research, the studies assessed the bioavailability of Vardenafil, a common PDE5 inhibitor for ED, comparing Spontan nasal spray to oral Vardenafil tablets.

Findings confirmed that Spontan achieves rapid absorption and faster onset of action compared to oral PDE5 inhibitors like Vardenafil, Sildenafil, and Tadalafil.

While oral PDE5 tablets are the current standard, they have a high discontinuation rate due to adverse reactions including headaches, acid reflex/heartburn, joint aches, backaches, dizziness, and more. They also take up to an hour to take effect and can be less effective with the consumption of food.

Spontan aims to address these issues, offering a fast-acting, on-demand ED treatment that could transform men’s lives.

Raising Spontan awareness among medical experts

LTR Pharma says it is introducing Spontan to market through a “meticulously managed” key opinion leader (KOL) strategy.

The company notes that the KOL approach enables it to gather real-world data and raise awareness within the medical community, paving the way for broader patient access in the future.

Hadley Barrett’s RSHC team is using Spontan for select patients who can benefit from a fast-acting nasal spray treatment for ED.

LTR Pharma says use of Spontan under the SAS program supports sustainable introduction of this product to the market, including:

Collection of real-world data by highly experienced medical professionals
Opportunity for KOLs to share experiences at international conferences and in publications
Building awareness and knowledge within the wider medical community

The Company announced in July it had raised $10.5m through a share placement to sophisticated and new institutional investors to advance regulatory pathways for Spontan.

‘Watershed moment’

LTR Pharma chairman Lee Rodne says dosing of the first patients under the SAS is significant for the company.

“The use of Spontan under the early access program marks a watershed moment for LTR Pharma,” he says.

“It demonstrates both the urgent need for fast-acting ED medication and Spontan’s potential to address a high unmet need for a fast and on-demand ED treatment and allows for hands-on, real-world experience with Spontan.”

Hadley Barrett says Spontan will be a valuable addition to the organisation’s therapeutic capability.

“Spontan complements our holistic approach, offering our patients an innovative option to help address their sexual health concerns and enhance overall well-being,” she says.

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.