Ltr Pharma
A Breakthrough In Erectile Dysfunction Treatment

LTR Pharma, a clinical-stage biopharmaceutical company, is pioneering the world’s first and only intranasal technology for treating erectile dysfunction (ED). SPONTAN, LTR’s phosphodiesterase-5 (PDE-5) inhibitor, delivers results on demand—in 10 minutes or less—unlike traditional solutions that can take an hour or more to work.

“ED can impact a man’s self-esteem, confidence, and mental well-being. We are treating it effectively, instantly and easily – empowering spontaneity in intimate moments,” says Lee Rodne, executive chairman.

Traditional medication, ingested orally, must first pass through the digestive system before reaching the bloodstream. Many of the widely used PDE-5 inhibitors, like Viagra, can cause unpleasant side effects such as stomach issues, diarrhea, headache, flushing, dizziness, heartburn, and joint or back pain during sexual activity. Due to these drawbacks, more than 50 percent of patients discontinue oral medication— which is considered the gold standard for first-line ED treatments—within a year.

SPONTAN has been clinically proven to address all these challenges. Applied intranasally, it achieves rapid absorption and a faster onset by bypassing the digestive system, providing men with greater control and confidence when it matters most. Its favorable safety profile and lower dosage also reduces the risk of side effects seen with traditional treatments, allowing men to experience greater comfort and confidence.

Quick Action, Happier Times

SPONTAN is a game-changer, entering the bloodstream instantly through the nasal cavity. Its efficiency is driven by the large surface area in the nasal cavity, allowing rapid drug absorption for fast results. Nasal administration also enables lower dosages than oral treatments, maximizing effectiveness while minimizing drug intake.

SPONTAN derives its name from the word 'spontaneity' and is designed to help men boost their confidence through its fast-acting nature. It is ideal for spontaneous moments, unlike oral medications that require prior planning. It restores control over timing in sensual and procreative experiences, allowing men to improve self-esteem issues and strengthen their relationships.

“Through SPONTAN, we aim to tackle the broader challenges of ED, which go beyond penile erection. The treatment also focuses on improving the mental wellbeing of men,” says Rodne.

A common myth about ED is that it can affect only older men. But it can affect males as early as their teen years. Reasons include pornography addiction that can lead to difficulties in becoming aroused with partners to medical conditions, and lifestyle changes. More than 150 million people worldwide have ED, and experts predict this number will reach 322 million by 2025.
Finding a viable cure for ED was a challenge that LTR Pharma confronted head-on. The Company’s research scientists initially were looking at finding ways to make FDA approved PDE-5 inhibitors to work faster. Later on, the Company went on to explore new delivery methods to improve the drug’s efficacy. After successfully developing the intranasal formula, it commercially optimized its PDE-5 inhibitor formulation to remove any discrepanciesseen with men across different age groups and medical conditions.

The research explored how factors like how delivery technologies like oral sprays, tablets, lozenges, and nasal sprays can influence the effectiveness of the treatment. The team has carefully modified the drug and nasal spray delivery technology to ensure it also works effectively for men with a history of medical issues including those recovering from severe conditions such as prostate cancer.

The clinical trials of intranasal PDE-5 inhibitor demonstrated a shorter time to reach peak concentration (Tmax). SPONTAN takes effect within 10 minutes compared to the average 56 minutes required for oral tablets.

In a bioequivalence study, LTR Pharma found that its nasal spray technology offers a superior alternative to PDE-5 tablets like Viagra. SPONTAN has an outstanding safety profile, with no participants dropping out during clinical trials. The drug’s efficiency means that only half the dosage is needed to achieve the same effect as a full oral tablet course.

Championing the Future of ED Treatment

SPONTAN is already prescribed in Australia under special access where the FDA approved tablets aren’t effective for men.

Australian doctors are increasingly gaining positive real-world clinical use and recommending the medication because of its consistent outcomes over traditional ED medications. LTR Pharma is seeking early access approvals in other jurisdictions, anticipating initialsales and clinical use of SPONTAN within the coming year.

In the U.S., LTR Pharma is focused on the FDA's expedited 505(b)(2) pathway, which facilitates changes to the delivery method of an already approved drug. With the oral formulation of SPONTAN already approved, the company is seeking approval for its intranasal spray version. The team has secured intellectual property rights for this formulation and plans to introduce the drug into the global market. The Company has scheduled a presubmission meeting with the FDA to submit a new drug application in 2025. This timeline is relatively quick for a new drug to enter the market.
In parallel, LTR Pharma is raising awareness about men's health issues, recognizing that education is vital to empowering individuals to take action. Encouraging men to consult with general practitioners and specialists, it aims to ensure that these concerns are addressed proactively, contributing to a healthier and more informed population.

The future looks promising for advancements in men's health as LTR Pharma plans to expand its nasal spray technology into other medications and indications.

Through SPONTAN, LTR Pharma is poised to revolutionize the treatment of erectile dysfunction, addressing a critical unmet need in men’s healthcare. More than just an ED treatment, SPONTAN is the fastest solution that promotes spontaneity and reliability while focusing on restoring confidence and strengthening relationships, ultimately enhancing quality of life, all in less than 10 minutes.