dm+d

Unassigned

Medicine Compliance Aid Stability

genericVarious generic versions

Various generic versions
generic
Tablets sublingual 300 micrograms, 500 micrograms, 600 micrograms
R1 · Red 1Stability data indicates that the drug is not suitable for CAs.
Unsuitable
Sublingual tablet, unsuitable for MCA.
9 November 2015

Lactation Safety Information

Rectal

Rectal
Yes
-
Limited published evidence of safety
Mothers should be advised to breastfeed the infant immediately before application of the ointment and to try to avoid breastfeeding for 1-2 hours after use to minimise infant exposure
11 July 2016

Buccal tablets / Parenteral / Transdermal

Buccal tablets / Parenteral / Transdermal
Caution
-
No published evidence of safety
Caution applies to chronic use. However, considered safe for short-term use
Monitor infants for flushing after feeding if shorter-acting formulations used
12 May 2017

Sublingual (Tablets / Spray)

Sublingual (Tablets / Spray)
Yes
-
No published evidence of safety
Sublingual use (tablets/spray) preferred to other formulations
12 May 2017

New Medicines

MED3000Erectile dysfunction, first-line - topical gel formulation using DermaSys technology

Information

MED3000
Medical Device
Future Medical Developments
Not Known

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Phase III Clinical Trials
May 22Launch timings have not been detailed; however the nature of the pharmacy market varies across Europe with countries such as the UK and Netherlands dominated by large retail chains. Market watchers suspect these will be the initial launch markets (probably in 2023), with retailers actively contributing to the promotional messaging. The next wave would likely include the key markets of France, Belgium, Germany, Italy, and Spain, with the third wave being the distributor-led smaller geographies [11].
May 22Futura Medical announces it has entered into an exclusive licensing agreement with Cooper Consumer Health for the rights to commercialise the MED3000 throughout the European Economic Area, UK and Switzerland. Cooper will be responsible for all launch and marketing expenses [10].
Dec 21Futura expect to progress registration in US via the medical device regulatory pathway. The FDA have requested an additional six-month confirmatory clinical study (FM71) prior to application. FM71 is expected to complete by Q2 2022 [8].
Apr 21Futura Medical progressed MED3000 (DermaSys) via the medical device regulatory pathway in 2020, and received a CE approval mark in April 21. The CE mark is recognised in Great Britain until 30 June 2023 and then Futura will secure the post-Brexit UKCA mark [8].
Sep 20Futura Medical plans regulatory submissions for Erectile dysfunction (Topical) with US FDA by the end of third quarter of 2020 [7].
Apr 20Futura Medical completes phase III FM57 trial in Erectile dysfunction in EU and plans to file for patent protection with regulatory submission for ED by July 20 [7].
Dec 19Futura Medical may be able to process its DermaSys technology through a medical devices regulatory path, following results from the PIII trial of MED2005 [5].
Jul 19Company plans to file to the MHRA [3].

Category

Topical nitrate applied using DermaSys technology, induces dilation of the cavernous and helicline arteries, thereby increasing blood flow to the lacunar spaces, coupled with nitrate-induced relaxation of trabecular smooth muscle.
The first large-scale community study - the Massachusetts Male Ageing Study - showed that 52% of men (aged 40-70 years) were affected at some time (mild 17%; moderate 25%; severe 10%). A Cologne study reported that ED was the most prevalent of the male sexual dysfunctions (prevalence age 30-80 years) at 19.2% vs. 31% for all types of male sexual dysfunction. This study equates to about 26 new cases annually per 1,000 men [1].
Erectile dysfunction, first-line - topical gel formulation using DermaSys technology
Topical

Trial or other data

Aug 21PIII 30 week open-label trial (NCT04984993) planned in US to compare MED3000 gel to tadalafil. The study is expected to complete in June 2022 [9].
Jan 20DermaSys is a drug delivery technology platform that provides rapid and targeted local delivery of an active pharmaceutical ingredient, such as GTN, at therapeutic levels to the required site of action. A gel containing a combination of solvents including volatile solvents is applied to the skin. The volatile solvents evaporate, leaving the remaining solvent supersaturated with GTN which then is rapidly absorbed through the skin [6].
Jan 20DermaSys is versatile and bespoke technology that can be tailored to suit the specific active compound being used and the therapeutic indication. Such drug delivery technology platform offers an optimised profile in terms of dose, onset time and duration of effect as well as an improved safety profile reducing the risks of side effects due to a lower systemic uptake. It is indicated that DermaSys incorporating topical gel GTN facilitate rapid absorption and effective delivery through the skin which translates into a fast onset of action (within 5-10 minutes) [6].
Jun 19PIII study (NCT03813992) is recruiting; timescales unchanged [4].
Nov 18PIII study (NCT03813992) to evaluate 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 starts. 1,000 men will be recruited in Bulgaria, Czechia, Georgia, Hungary, Latvia, Poland, Russian Federation, Slovakia and Ukraine. Collection of primary outcome data (International Index for Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile (SEP) Questionnaire (Question 2 and Question 3)) is expected to complete Oct 19 [2].

Evidence based evaluations