Local pharma sets eyes on Bayer’s Levitra

Pharma News: Levitra (vardenafil hydrochloride) is an erectile dysfunction (ED) medication first manufactured by the Bayer Pharmaceuticals in 2003 as a competitor to Viagra (sildenafil citrate).

Brisbane-based LTR Pharma has secured ethics approval for a bio-equivalence clinical study of its unique intranasal spray for erectile dysfunction, Spontan – a crucial step in fast-tracking approval for this world-first product with the U.S. Food and Drug Administration (FDA).

LTR Pharma was spun-out of LTR Medical, a medical device and distribution business that works with international and domestic manufacturers to commercialise medical technologies. Spontan’s intranasal delivery technology 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.

LTR Pharma Executive Chairman and Chief Executive Officer, 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 2028.

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 apray Spontan with the FDA approved ED drug Levitra.

The trial will compare the pharmacokinetics, safety and tolerability of Vardenafil following administration of Spontan 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 in Q3 this year.

LTR Pharma collaborated with founding researcher from California, Professor Moses Chow, who developed 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.

The Royal Australian College of General Practitioners (RACGP) reports that erectile dysfunction is a very common clinical problem managed in primary care. It can contribute to relationship breakdowns and mental health issues. It’s estimated the condition will affect around 40% of men, with the prevalence increasing with age.

In reimagining healthcare, Health Industry Hub^TM is the ONLY one-stop-hub uniting the diversity of Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change. The exclusive leadership and influencer podcasts and vodcasts offer unparalleled insights and add immense value to our breaking news coverage.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.