Sydney, Australia – 16 August 2024 | LTR Pharma Limited (ASX: LTP) ("LTR Pharma" or "the Company") is pleased to announce another milestone in introducing SPONTAN®, its innovative nasal spray treatment for Erectile Dysfunction (ED), to the market. SPONTAN® has now been prescribed to its first patients under the Therapeutic Goods Administration's (TGA) Authorised Prescriber Scheme (APS), in addition to its first prescriptions via the Special Access Scheme announced on 5 August 2024.
Highlights:
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APS Milestone: The TGA’s Authorised Prescriber Scheme has allowed medical practitioners to prescribe SPONTAN® to a broader class of patients with erectile dysfunction, as opposed to on a case-by-case basis, as is required under the TGA’s Special Access Scheme (SAS). This alternative will facilitate another efficient pathway for patient access to SPONTAN®.
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Renowned Expert & Key Opinion Leader Participation: Leading the initial prescriptions under the APS is Professor Eric Chung, a recognised expert in urology, as well as men's health. Professor Chung's participation in rolling out SPONTAN® underscores the growing recognition of its potential in addressing unmet needs for those who require treatment for ED.
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Real-World Impact: The APS enables authorised healthcare professionals to gain hands-on experience with new treatments like SPONTAN® in practical, real-world settings. This also provides valuable data and insights that will support broader market introduction of the treatment..
LTR Pharma Chief Scientific Advisor, Professor Eric Chung said: “The Authorised Prescriber Scheme allows us to offer SPONTAN to a wider range of patients who may benefit from its rapid onset of action. This innovative nasal spray has the potential to significantly improve quality of life for men struggling with ED and offers a new treatment option, particularly for those seeking a more spontaneous solution.”
LTR Pharma Chairman, Mr. Lee Rodne said: “The authorisation of SPONTAN under the Authorised Prescriber Scheme represents an important milestone for LTR Pharma. It emphasises the pressing need for a faster-acting erectile dysfunction treatment option and highlights SPONTAN's capacity to fulfil a significant unmet need for an on-demand ED solution. This scheme enables authorised healthcare professionals to obtain meaningful, hands-on experience with SPONTAN in real-world settings.”
About the Authorised Prescriber Scheme:
The TGA Authorised Prescriber Scheme allows registered medical practitioners to prescribe unapproved therapeutic goods to a class of patients with a particular medical condition without needing individual patient approvals. This significant development aligns with the Company's strategic approach to introducing SPONTAN through a carefully controlled, KOL-driven pathway. Under the Authorised Prescriber Scheme, designated medical practitioners can supply SPONTAN to patients who have not responded to approved treatments, thereby addressing unmet medical needs determined by these authorised healthcare professionals.
For further information, please contact:
Haley Chartres
Media Relations
haley@hck.digital
Peter McLennan
Investor Relations
investors@ltrpharma.com
About us:
About LTR Pharma:
LTR Pharma is focused on improving men’s health, physically and mentally, through the commercialisation of an innovative nasal spray treatment for Erectile Dysfunction. ED is a pressing health issue for millions of men that can negatively impact self-esteem and relationships across multiple age brackets. LTR Pharma’s lead product SPONTAN® is set apart from existing ED therapies by its mechanism of action – intranasal delivery technology of a PDE5 inhibitor. The nasal cavity is a highly vascular part of the body, supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less. LTR Pharma is proudly aiming to restore greater control over the timing, spontaneity, and enjoyment of sexual experiences.
Contact details:
Jane Morgan
Jane Morgan Management
Investor & Media Relations
jm@janemorganmanagement.com.au