Ethics approval received to test SPONTAN® in pulmonary arterial hypertension
LTR Pharma has received ethics approval for a clinical study of SPONTAN® in pulmonary arterial hypertension (PAH). PAH represents a significant global therapeutics market, estimated at US$8.0 billion in 2024 and forecast by third-party sources to reach up to US$17.9 billion by 2034. What is pulmonary arterial hypertension (PAH)? PAH is a serious, progressive and currently […]
Over 2,000 SPONTAN® units dispensed under Special Access Scheme
LTR Pharma Limited (ASX:LTP) has announced that more than 2,000 bottles of SPONTAN®, our rapid-onset intranasal vardenafil spray, have been dispensed in Australia under the Therapeutic Goods Administration (TGA) Special Access Scheme. Highlights: More than 2,000 bottles of SPONTAN® dispensed in Australia under the TGA Special Access Scheme and Authorised Prescriber pathways Over 120 established […]
First ROXUS® prescriptions fulfilled in the United States
LTR Pharma (ASX: LTP) has confirmed the first patient-specific ROXUS® prescriptions received through Mavrox, Shed’s men’s health telehealth platform, have now been fulfilled in the United States. ROXUS is LTR Pharma’s intranasal medication for erectile dysfunction support. The milestone marks the start of prescription activity under LTR Pharma’s agreements with U.S. partners Shed and Strive […]
Watch: Melissa Hadley Barrett explains SPONTAN® real-world data presented at APCC
At the Asia-Pacific Prostate Cancer Conference (APCC) in Melbourne, Nurse Practitioner and Sexologist Melissa Hadley Barrett presented outcomes from 147 men who used SPONTAN nasal spray with a 93% response among men seeking greater convenience and spontaneity. The retrospective study included 147 treatment-experienced men prescribed SPONTAN® in routine Australian clinical practice, making it the largest real-world dataset reported […]
Final Phase II report confirms SPONTAN® six-fold faster absorption
LTR Pharma has received the final Clinical Study Report for its SPONTAN® Phase II pharmacokinetic study. The report completes the pharmacokinetic dataset agreed with the FDA for LTR Pharma’s planned U.S. 505(b)(2) submission. LTR’s SPONTAN® is a fast-acting intranasal spray for the treatment of erectile dysfunction, enabling an onset of action in 10 minutes or […]
LTR Pharma Expands Men’s Health Platform Through Exclusive KYZATREX® Pilot Commercialisation Agreement in Australia
LTR Pharma has entered into an exclusive pilot commercialisation agreement with Marius Pharmaceuticals, a US pharmaceutical company focused on men’s health, to introduce Marius’ lead product, KYZATREX® (testosterone undecanoate oral capsules), in Australia. KYZATREX is FDA-approved and commercially available in the United States. Strategic rationale Testosterone deficiency affects energy, mood, muscle mass, bone density and […]
LTR Pharma Executes Definitive U.S. Commercial Agreement with Strive Pharmacy
LTR Pharma has executed a definitive Compounding and Supply Agreement with Strive Specialties Inc., a leading U.S. Section 503A compounding pharmacy, converting the previously announced binding Term Sheet into a definitive commercial agreement governing the planned manufacturing, compounding, fulfilment and nationwide supply of ROXUS® in the United States. The agreement establishes the operational framework for technology transfer, manufacturing, quality systems, […]
LTR Pharma Executes Definitive U.S. Commercial Agreement with Shed
LTR Pharma has executed a definitive Telehealth Distribution Agreement with Shed Holdings LLC, a leading U.S. direct-to-consumer telehealth platform, converting the previously announced binding Term Sheet into a definitive commercial agreement governing the planned U.S. commercialisation of ROXUS®. The agreement establishes the commercial framework for the planned U.S. commercialisation of ROXUS. Shed will commercialise ROXUS through Mavrox™, its dedicated men’s […]
ROXUS® US Pharmacy Partner Secured
LTR Pharma has signed a term sheet with Strive Specialties, a United States personalised medicine and 503A pharmacy for ROXUS®. This establishes the pharmacy fulfilment infrastructure required to supply ROXUS in the US and follows our announcement earlier this week that Shed Holdings, a direct-to-consumer (DTC) telehealth platform, will be a US distributor for this novel intranasal spray. Our […]
SPONTAN® now available | Erectile Dysfunction (ED) is more prevalent and severe with age
News update: Leading Australian medical experts are driving public awareness and conversation about the increased severity and prevalence of sexual issues in men aged 65+, with a focus on Erectile Dysfunction (ED). Men in their 40’s have about a 40% chance of experiencing some form of ED, with prevalence increasing about 10% per decade thereafter[1]. […]
Edison Group Research Report
Edison has released a report on LTR Pharma, highlighting the clinical validation of SPONTAN as a fast-acting intranasal treatment for erectile dysfunction and its progression toward regulatory submission. The report also covers our platform expansion into new markets through ROXUS and OROFLOW, alongside portfolio diversification via our recent investment in LevOmega. The author notes: “With […]
LTR Pharma increases ownership in LevOmega to ~43% through strategic A$1m investment
LTR Pharma has announced that it has increased its ownership in LevOmega Pty Ltd from 33% to approximately 43%. Through its wholly owned subsidiary, LTR Spectrum Pty Ltd, LTR Pharma has invested A$1.0 million to support the advancement of LevOmega’s research and development programs. LevOmega was co-founded by LTR Pharma, Levur Pty Ltd and Green […]
Conversation Series | Treating Erectile Dysfunction with Melissa Hadley Barrett
In recognition of September being Sexual Health Awareness Month, we’re pleased to share the latest episode of our Conversation Series, featuring Sexologist and Nurse Practitioner Melissa Hadley Barrett. In this episode, Melissa explores a range of treatment options for erectile dysfunction (ED) — from oral medications like Viagra and Cialis to injectable therapies and our […]
SPONTAN® achieves 100% patient satisfaction in post-prostatectomy case series
Clinical collaborator and men’s health expert Melissa Hadley Barrett from Make Hard Easy and the Restorative Health Clinic presented a case series at the Asia-Pacific Prostate Cancer Conference (APCC) in Sydney demonstrating the efficacy of SPONTAN in men suffering ED following radical prostatectomy. The results were compelling: 100% patient satisfaction with SPONTAN treatment All patients […]
SPONTAN® Strengthens Commercial Position with 18-Month Shelf Life Achievement
LTR Pharma has announced that SPONTAN® has achieved an 18-month shelf life under International Council for Harmonisation (ICH) stability conditions – a significant milestone that strengthens its commercial position in the global ED market. Achieving an 18-month shelf life under ICH standards demonstrates that SPONTAN is ready for large-scale distribution. Specifically, this milestone: Confirms the […]
US Men’s Health Expert, Dr Andrew Sun, Joins LTR Pharma’s Scientific Advisory Board
LTR Pharma is pleased to announce the appointment of Dr Andrew Y. Sun, M.D., a fellowship-trained urologist and nationally recognised expert in male sexual and reproductive medicine, to its Scientific Advisory Board. Based in Texas, Dr Sun brings extensive experience in prescribing PDE5 treatment protocols and will advise on integrating LTR’s intranasal therapies ROXUS ® […]
Dr Amy Pearlman Joins LTR Pharma’s Scientific Advisory Board
Dr Amy Pearlman, M.D., a board-certified urologist and nationally recognised leader in sexual medicine, has joined the LTR Pharma’s Scientific Advisory Board. Dr Pearlman is Co-founder of Prime Institute in Florida and a fellowship-trained specialist in male sexual and hormonal health. She is a former Director of the Men’s Health Program at the University of […]
The Australian | LTR Pharma completes study milestone for SPONTAN® ED treatment
The Australian has published a Special Report titled ‘LTR Pharma completes study milestone for SPONTAN ED treatment’, outlining that LTR Pharma has completed a key extractables study for its SPONTAN intranasal spray for erectile dysfunction and kicked off a leachables study as part of a regulatory development program. “The completion of our extractables study and […]
LTR Pharma Completes Extractables Study Milestone for SPONTAN®
LTR Pharma has completed extractables studies for SPONTAN®, its intranasal spray for erectile dysfunction, with co-development partner Aptar Pharma. All identified compounds were confirmed below ICH safety thresholds. This milestone represents a required step in the Company’s FDA 505(b)(2) regulatory submission pathway. The FDA requires Extractables and Leachables (E&L) studies for all pharmaceutical products to […]
Conversation Series | Lifestyle Factors and Erectile Dysfunction with Melissa Hadley Barrett
In the third episode of our Conversation Series, Sexologist and Nurse Practitioner, Melissa Hadley Barrett reveals the surprising lifestyle factors that significantly impact men’s sexual health. Melissa explains why smoking is “the biggest penis killer,” how excess weight blocks blood flow, and reveals that for every 16kg a man gains, he can lose up to […]