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A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period

An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected to participate for up to 30 weeks. Eligible patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.

开始日期2021-09-14

申办/合作机构

Futura Medical Developments Ltd.

EUCTR2017-000960-14-CZ / Not yet recruiting临床3期

A Phase III, dose ranging, multi-centre, randomised, double blind, placebo controlled, home use, parallel group clinical trial of topically-applied glyceryl trinitrate (GTN) for the treatment of erectile dysfunction (ED) with an open label extension.

开始日期2019-01-07

申办/合作机构

Futura Medical Developments Ltd.

NCT03813992 / Completed临床3期

A Phase III, Dose Ranging, Multi-centre, Randomised, Double Blind, Placebo Controlled, Home Use, Parallel Group Clinical Trial of Topically-applied Glyceryl Trinitrate for the Treatment of Erectile Dysfunction, With an Open Label Extension

To demonstrate the efficacy of various doses of MED2005 versus placebo in male patients with clinically diagnosed erectile dysfunction, and to evaluate the long-term efficacy and safety (12 months) of MED2005.

开始日期2018-11-01

申办/合作机构

Futura Medical Developments Ltd.

100 项与 Futura Medical Developments Ltd. 相关的临床结果

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0 项与 Futura Medical Developments Ltd. 相关的专利（医药）

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项与 Futura Medical Developments Ltd. 相关的文献（医药）

2023-07-06·The Journal of Sexual Medicine

(314) MED3000, A CLINICALLY PROVEN, FAST-ACTING TOPICAL PRODUCT FOR ERECTILE DYSFUNCTION WITH THE PROSPECT OF BEING THE FIRST GLOBALLY AVAILABLE OTC TREATMENT FOR ED

作者: Tim, Holland ; Dr. David, Ralph ; Ken, James

AbstractObjectivesTo assess the effectiveness, onset of action and safety of MED3000 gel over a 24-week treatment period in male patients clinically diagnosed with ED.Methods100 male patients clinically diagnosed with ED were randomised into two treatment groups, 50 to MED3000 and 50 to Tadalafil (5mg) in 11 Investigational sites in USA, Poland Georgia and Bulgaria.ResultsBoth Co-Primary end points were achieved (P<0.001) (1) Mean IIEF-EF change from baseline at 24 weeks (2) Minimal clinically important difference (MCID) exceeded at 24 weeks). 61% of MED3000 users exceeded the MCID at 24 weeks The mean IIEF score at weeks 4, 8, 12, 16, 20, 24 was 4.59, 5.20, 5.12, 5.83, 5.57 5.73 Secondary Endpoint 10 minute onset of action FDA agreed standard for achieving a 10 minute onset of action was achieved. A key differentiator from PDEi's Effective in Mild, Moderate and Severe ED MED3000 also delivered a clinically meaningful outcome over 24 weeks in accordance with the Rosen 2, 5 and 7 criteria (Rosen et al 2011)1 in mild, moderate and severe ED subjects Adverse Events (<2 incidences) are detailed in figure 1.Reference1 – Rosen RC et al “Minimal clinically important differences in the erectile function domain in the International Index of Erectile Function Scale Eur Urol 2011;60(5):1010-6ConclusionsMED3000 has been shown to deliver a clinically meaningful response and is fast-acting. It was also shown to be clinically effective in mild, moderate and severe ED. Results were generally consistent with a previously conducted clinical study used for European approval MED3000 was shown to have minimal adverse events. Its “drug-free” formula provides a further margin of safety with no propensity for adverse drug interactions. This profile makes it suitable for OTC use.FDA filing for marketing authorisation as a De Novo medical device occured in October 2022.Conflicts of InterestProfessor David Ralph is a consultant to FMD Tim Holland and Ken James are employees of FMD The study was funded by FMD (Not for promotional purposes in the US).

2020-01-01·The Journal of Sexual Medicine

114 Ultrasound Doppler Measurements of Penile Blood Flow as a Predictor of Clinical Efficacy

作者: Holland, T.

2020-01-01·The Journal of Sexual Medicine

031 Establishing the Safety Profile in Sexual Partners of a New Topical Nitroglycerin Gel for the Treatment of Erectile Dysfunction

作者: Holland, T. ; James, K. ; Armstrong, I.

100 项与 Futura Medical Developments Ltd. 相关的药物交易

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100 项与 Futura Medical Developments Ltd. 相关的转化医学

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