Starpharma suffers setback after US FDA appeal rejected
LTR Pharma to commence study on erectile dysfunction nasal spray, SPONTAN
Starpharma suffers FDA setback
Starpharma (ASX:SPL) fell -10% this morning after announcing a negative outcome in its appeal to the US FDA.
The FDA has maintained its position that it requires additional clinical efficacy data to be generated for the regulatory approval of Starpharma’s VivaGel BV for bacterial vaginosis (BV) in the US.
The formal dispute resolution process had involved multiple submissions, meetings, detailed analyses, and the preparation of regulatory precedents relating to recent product approvals.
Starpharma had engaged highly experienced regulatory advisers, key opinion leaders, and biostatistical and legal advisers, including several who were ex-FDA, throughout the process.
“Naturally, this is not the outcome Starpharma was hoping for,” said Starpharma’s CEO, Cheryl Maley.
“Whilst we explore opportunities to enter the US market in the future, Starpharma will not prioritise conducting another VivaGel BV clinical trial.”
Currently, the VivaGel BV’s NDA (New Drug Application) application remains open (Fast Track and QIDP status).
Starpharma says it remains committed to leveraging the VivaGel BV development program, and will work to maximise the commercial opportunities for VivaGel BV in the more than 45 markets where it is already approved.
The decision by the FDA does not alter the approval status in these countries.
LTR Pharma to commence SPONTAN study
Elsewhere, LTR Pharma (ASX:LTP) has commenced patient recruitment for its SPONTAN clinical study.
SPONTAN is the company’s novel treatment for Erectile Dysfunction (ED), and was designed as a world-first, fast acting, on-demand nasal spray treatment for ED.
The study will be conducted in Sydney, in partnership with Southern Star Research and Scientia Clinical Research.
It will assess the relative bioavailability of Vardenafil – a widely used PDE5 inhibitor to treat ED – following administration of SPONTAN nasal spray, when compared to oral delivery of Vardenafil tablets alone.
These oral PDE5 tablets are currently the gold standard treatments, but have a high discontinuation rate with consumers.
SPONTAN is designed to overcome the issues with oral PDE5 tablets, and to be a fast acting-on demand treatment for ED, potentially transforming men’s lives.
Data from the study will be used in SPONTAN’s US FDA regulatory submissions.
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