Men now have an alternative to erectile dysfunction (ED) pills with the first prescriptions in Australia issues for SPONTAN, a nasal spray manufactured by LTR Pharma (ASX: LTP) which has been fast-tracked by regulators to address what they define as an “unmet medical need”. 

Prescriptions of SPONTAN are being issued under the Therapeutic Goods Administration’s (TGA) allocation of the product under the Special Access Scheme (SAS) which recognises its potential to address unmet medical needs and improve the quality of life for millions of men.

Erectile dysfunction is a common condition that affects men of various ages, often leading to diminished self-esteem and strained relationships. Traditional ED treatments, while effective for many, can have limitations regarding the onset of action and spontaneity of sexual activity. LTR Pharma’s SPONTAN represents a novel approach, utilising intranasal delivery technology to administer a PDE5 inhibitor. The nasal cavity’s rich vascular structure allows for rapid drug absorption, enabling SPONTAN to take effect within 10 minutes, providing a quicker and more spontaneous solution compared to oral medications.

Melissa Hadley Barrett, founder of the Restorative Sexual Health Clinic, highlighted the therapeutic benefits of the spray. 

“We see SPONTAN as a valuable addition to our therapeutic capability. It complements our holistic approach, offering our patients an innovative option to help address their sexual health concerns and enhance overall well-being,” said Barrett. 

The clinic’s patients are among the first in Australia to experience this cutting-edge treatment, marking a pivotal advancement in ED therapy.

The TGA’s SAS allows health practitioners to prescribe unapproved therapeutic goods on a case-by-case basis, facilitating compassionate use for patients with significant health needs. This regulatory pathway has enabled LTR Pharma to introduce SPONTAN to the market through a carefully managed, Key Opinion Leader (KOL)-driven approach. By doing so, the Company aims to gather real-world data and insights that will support broader regulatory approval and market acceptance.

The introduction of SPONTAN in Australia is timely, as there is a growing recognition of the importance of addressing men’s health issues comprehensively. Erectile dysfunction, while often under-discussed, has significant implications for mental health and relationship satisfaction.

Getting their product into the hands of Australians has been well received by investors with LTP shares trading more than 3x the Company’s $0.20 IPO Offer Price when the Company listed on the ASX in December 2023, as the first ED business on the local exchange. 

For the year ended 30 June 2024, LTR Pharma reported $5.1 million in net cash operating outflow but hopes that will start turning with revenue the product having now been commercialised to start generating revenue. 

Spontan is still subject to approval in the United States but its latest clinical data demonstrated rapid absorption and a faster time to peak concentration in as little as 9 minutes with an average of 12 minutes compared to traditional oral PDE5 inhibitors (e.g. Viagra) which averaged 56 minutes.