Australian Innovators Pursue $3.6Bn Erectile Dysfunction (ED) Market
Brisbane-based LTR Pharma has today secured Ethics Approval for a bio-equivalence1 clinical study of its intranasal spray for erectile dysfunction (ED), ‘SPONTAN™’ – a crucial step in fast-tracking approval for this world-first product with the U.S. Food and Drug Administration (FDA).
SPONTAN’s unique delivery technology (‘Intranasal’) bypasses the digestive system and is designed to overcome the issues of other ED oral tablets by having a significantly faster onset of action within 5-15 minutes.
Erectile dysfunction (ED) is a condition in which a person is unable to get or keep an erection firm enough for satisfactory sexual intercourse. ED can be a short-term or long-term problem, contributing to relationship breakdowns and mental health issues. ED impacts approximately 30 million people in the US alone.
LTR Pharma Executive Chairman and Chief Executive Officer, Mr Lee Rodne, said SPONTAN has the potential to revolutionise the way men manage ED.
“SPONTAN is a truly innovative, fast-acting treatment, which is on track to disrupt the established blockbuster oral PDE5 market. Current oral tablets such as Viagra can take up to one hour to take effect, and many men are dissatisfied with the results as they don’t always work or in the time desired,” said Mr Rodne.
“We are thrilled to have received ethics approval for this pivotal clinical study – a crucial step in clinical validation and our expedited regulatory journey, as we prepare to market this product around the world,” said Mr Rodne.
The global market for erectile dysfunction treatments is estimated to be worth USD $3.6Bn in 2021 and is expected to grow to USD $5.9Bn by the end of 20282.
LTR Pharma is pursuing the expedited FDA 505(b)(2) regulatory process, which governs a change of route in administration of an already approved drug. The Company has now received approval from the Bellberry Human Research Ethics Committee (‘HREC’) for a bioequivalence clinical trial comparing its proprietary multi-use Nasal Spray SPONTAN™ with the FDA approved ED drug Levitra®.
The trial will compare the pharmacokinetics, safety and tolerability of Vardenafil following administration of LTR’s Nasal Spray (SPOTAN™) and Levitra tablets in healthy male adults. Patient recruitment is expected second half of this year, with trial sites set to be opened in Sydney, Australia in Q3 CY23.
1 Bioequivalence is the biochemical similarity of two drugs that share the same active ingredient and desired outcome(s) for patients. Bioequivalence testing does not require a full clinical trial process that the name-brand version had to go through. https://www.investopedia.com/terms/b/bioequivalence.asp#:~:text=What%20Is%20Bioequivalence%3F,outcome(s)%20for%20patients.
LTR Pharma was spun-out of LTR Medical Pty Ltd – a successful and profitable medical device and distribution business that works with international and domestic manufacturers to commercialise medical technologies. Its core business includes medical device nasal spray sales in Australian Hospitals and most recently, supplying speciality medical infusion devices in response to the COVID- 19 pandemic.
LTR Pharma collaborated with founding researcher from California, Professor Moses Chow, who developed a proprietary compound (SDS089 now called SPONTAN) as a Nasal Spray to treat patients with erectile dysfunction. LTR Pharma has in-licensed on a global exclusive basis all rights to develop, manufacture, commercialise and sell the compound as a nasal spray product.
For more information visit LTR Pharma.
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LTR Pharma Executive Chairman and Chief Executive Officer, Mr Lee Rodne, is available for comment and photo opportunities. Please contact:
H^CK Director, Haley Chartres
- +61 423 139 163
ABOUT LTR PHARMA LTD
LTR Pharma is a late-stage clinical pharmaceutical company that is commercialising a ‘First in Class’ rapid on demand treatment for Erectile Dysfunction (ED) – SDS089 or “SPONTAN”. ED is a serious and common medical problem with significant impacts to both physical and psychological health. ED has been identified as a major factor in relationship breakdowns and the worldwide prevalence has doubled in the last 30 years and is expected to increase to 322 million in 2025.
Spontan™ (SDS089) is designed as a fast acting, on-demand Nasal Spray treatment for Erectile Dysfunction. In its proof-of-concept human study, Spontan showed the characteristics to be a fast- acting treatment within 5-15 minutes compared to oral tablets that can take up to 60 minutes to take effect.