Business
MED2002 Regulatory Update
MED2002 Regulatory Update.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \nRNS Number : 6256G Futura Medical PLC 31 May 2017 \n\nFor immediate release 31 May 2017\n \n \nFutura Medical plc\n(\"Futura\" or the \"Company\")\nMED2002 Regulatory Update\nFutura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to provide the following update on its discussions with US and UK regulatory authorities on the clinical trial requirements and regulatory pathway for MED2002, the Company's topical gel for erectile dysfunction (\"ED\").\nSummary and Highlights\n· Written responses received from regulators (the US FDA and the UK MHRA) on regulatory pathway for MED2002 \n· Responses support the Company's expectations, including on timing for regulatory submissions for marketing authorisations, anticipated in Q2 2019 following data from studies to be initiated in Q4 2017\n· Recommendations to evaluate at higher doses to optimise efficacy across the spectrum of all ED patients, as well as to obtain limited additional safety data \nThe planned Phase III programme follows the successful clinical results announced on 7 September 2016, confirming MED202 had met its primary endpoint and showed efficacy, safety and speed of onset. MED2002's rapid onset of action means that it has the potential to be the world's fastest-acting treatment for ED.\nJames Barder, Futura's Chief Executive, commented: \"We are delighted by the constructive feedback provided on the remaining development pathway for MED2002, our topical gel for ED, from both the US and UK regulatory authorities. We believe that to have the remaining development programme aligned with the authorities' suggestions, and with no expected impac...