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Presents Data on MED2005 at SMSNA Annual Meeting
Presents Data on MED2005 at SMSNA Annual Meeting.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \nRNS Number : 8447G Futura Medical PLC 09 November 2018 \n\nFutura Medical Presents Data on MED2005 for the Treatment of Erectile Dysfunction at the 19th Annual Fall Scientific Meeting of Sexual Medicine Society of North America (SMSNA)\n \n9 November 2018\n \nFutura Medical plc (AIM: FUM) (the \"Company\"), a pharmaceutical company developing a portfolio of innovative products for sexual health and pain relief, today announces that it will be presenting data on its DermaSys® drug delivery technology and lead product MED20051, a topical glyceryl trinitrate (\"GTN\") gel for the treatment of erectile dysfunction (\"ED\"), at the 19th Annual Fall Scientific Meeting of SMSNA, on 8-11 November 2018 at the Loews Miami Beach Hotel, Miami, Florida USA.\n \nTim Holland, Director of Clinical Development at Futura Medical, will give an oral presentation (#155) entitled \"Pharmacokinetics (PK) of MED2005, a Topical Glyceryl Trinitrate Gel for the Treatment of Erectile Dysfunction2\" on Friday 9 November at 16:25 EST. The presentation will be part of the 'Erectile Dysfunction (Medical) - Moderated Posters' session.\n \nThe PK data to be presented demonstrate that MED2005 has been shown to have a rapid absorption, good bioavailability and an acceptable safety profile at doses higher than 0.2% studied in the previously reported Phase 2 clinical study (\"FM53\"). In addition, the PK study demonstrated similar or lower bioavailability of GTN when administered via MED2005 compared with Nitrostat® at doses 0.2%, 0.4%, and 0.6% GTN.\n \nResults also demonstrated that plasma concentrations of GTN and its two major metabolites increased proportionally with increasing MED2005 dosage. The highly encouraging results build on the data from FM53 that demonstrated statistically significant benefit over placebo in humans using the internationally accepted IIEF-EF trial endpoints. This supports the Company's strong belief that the higher dose forms of MED2005 should improve efficacy with an acceptable safety profile and meet US FDA's requirements for the simplified 505(b)2 regulatory pathway. Results of FM53 were published in a peer reviewed paper in The Journal of Sexual Medicine in February 2018.\n \nJames Barder, Chief Executive Officer of Futura Medical, said: \"We are very pleased to share in more detail these me...