LTR Pharma
Clinical-stage biopharmaceutical company based in Brisbane, Australia, focused on development and commercialisation of an intranasal drug-delivery platform for PDE5 inhibition intended to treat erectile dysfunction. Activities include formulation and manufacturing development for intranasal delivery, clinical pharmacokinetic and bioequivalence studies, regulatory pathway progression (including FDA 505(b)(2) strategy and TGA special access engagement), and commercial distribution partnerships in Australia.
Industries
Nr. of Employees
small (1-50)
LTR Pharma
Products
Intranasal PDE5 inhibitor spray (lead product)
An intranasal formulation of a PDE5 inhibitor developed for rapid onset of action and reduced systemic exposure compared with oral tablets; advanced through proof-of-concept and bioequivalence study planning for regulatory submission.
Intranasal spray development for oesophageal motility disorders (development project)
Development program to adapt intranasal delivery technology to provide rapid symptom relief for oesophageal motility disorders.
Intranasal PDE5 inhibitor spray (lead product)
An intranasal formulation of a PDE5 inhibitor developed for rapid onset of action and reduced systemic exposure compared with oral tablets; advanced through proof-of-concept and bioequivalence study planning for regulatory submission.
Intranasal spray development for oesophageal motility disorders (development project)
Development program to adapt intranasal delivery technology to provide rapid symptom relief for oesophageal motility disorders.
Services
Collaborative development agreements with external formulation and device partners to develop intranasal spray products for multiple clinical indications.
Distribution, warehousing and inventory management through a national pharmaceutical wholesaler to supply community pharmacies.
Collaborative development agreements with external formulation and device partners to develop intranasal spray products for multiple clinical indications.
Distribution, warehousing and inventory management through a national pharmaceutical wholesaler to supply community pharmacies.
Expertise Areas
- Intranasal drug delivery
- Clinical trial management and bioequivalence studies
- Pharmacokinetics and bioavailability assessment
- Formulation development for transmucosal absorption
Key Technologies
- Intranasal drug delivery
- Transmucosal absorption-enhanced formulations
- Pharmacokinetic (PK) analysis
- Bioequivalence study design
News & Updates
Independent research report highlighting clinical validation of the intranasal treatment and platform expansion activities.
Company increased ownership stake in LevOmega Pty Ltd to approximately 43% to support R&D programs.
Stability testing under ICH conditions established an 18-month shelf life for the intranasal product.
Extractables study on nasal spray components completed; identified compounds were below ICH safety thresholds as part of regulatory development.
Clinical collaborator presented a case series reporting patient satisfaction data for the intranasal treatment in men after radical prostatectomy.
Ethics approval secured for a bioequivalence clinical study comparing intranasal and oral formulations; trial sites planned in Australia.
Independent research report highlighting clinical validation of the intranasal treatment and platform expansion activities.
Company increased ownership stake in LevOmega Pty Ltd to approximately 43% to support R&D programs.
Stability testing under ICH conditions established an 18-month shelf life for the intranasal product.
Extractables study on nasal spray components completed; identified compounds were below ICH safety thresholds as part of regulatory development.
Clinical collaborator presented a case series reporting patient satisfaction data for the intranasal treatment in men after radical prostatectomy.
Ethics approval secured for a bioequivalence clinical study comparing intranasal and oral formulations; trial sites planned in Australia.