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Asia

LTR Pharma Gets Ethics Committee Approval for Trial of Intranasal Spray in Patients With Oesophageal Motility Disorders

LTR Pharma (ASX:LTP) received ethics committee approval for a clinical study to evaluate its Oroflow intranasal spray in patients with oesophageal motility disorders, which impede the food swallowing function, according to a Wednesday filing with the Australian bourse.The company expects to initiate the study in the coming quarter to assess Oroflow's effect in healthy volunteers before progressing to patients with the disorders."As a non-invasive intranasal spray, Oroflow may be particularly suited to patients with swallowing difficulties, removing the need to take an oral tablet while offering a rapid route of administration," the company said.

ASX:LTP
Asia

LTR Pharma Establishes Exclusive US Pharmacy Fulfilment Rights for Erectile Dysfunction Product, Shares Jump 22%

LTR Pharma (ASX:LTP) executed a binding term sheet with Strive Specialties, establishing exclusive US pharmacy fulfilment rights for its intranasal erectile dysfunction treatment product ROXUS, according to a Thursday Australian bourse filing.The term sheet provides access to a multi-state 503A pharmacy platform to support national pharmacy fulfilment.The agreement has a two-year initial term from commercial launch, with annual autorenewal unless either party elects not to renew. The product will be supplied through a multi-channel strategy incorporating telehealth, pharmacy fulfilment, and healthcare provider networks.Its shares soared 22% in recent trading on Thursday.

ASX:LTP
Asia

LTR Pharma Says Interim Phase Two Data for Erectile Dysfunction Treatment Candidate Shows Rapid Time to Peak Concentration, Shares Jump 28%

LTR Pharma (ASX:LTP) said that interim phase two pharmacokinetic and safety data for its intranasal spray for erectile dysfunction, SPONTAN, showed a rapid time to peak concentration and a consistent safety profile, according to a Friday Australian bourse filing.The study characterized the key pharmacokinetic parameters requested by the US Food and Drug Administration (US FDA), including rapid absorption, repeat-dose behavior, and consistency across adult and geriatric populations. The data support its planned FDA 505(b)(2) regulatory pathway, subject to completion of final statistical analysis, per the filing.SPONTAN (five milligrams) demonstrated a median Tmax of 10 minutes, compared with a median Tmax of 60 minutes for the 20mg vardenafil oral tablet. The Tmax range for SPONTAN was 10 minutes to 15 minutes,compared with 30 minutes to 180 minutes for the oral tablet.Pharmacokinetic profiles in subjects aged over 65 years were comparable to those in the adult cohort, with no apparent differences observed in the dataset. Intranasal administration of SPONTAN over five consecutive days did not result in drug accumulation.No serious or severe treatment-emergent adverse events were observed, per the filing.Its shares rose 28% in recent trading on Friday.

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