MED2005 Safety and Efficacy Data Reported at SMSNA
New Clinical Data Provide Additional Validation for the Safety and Efficacy of Futura Medical's Topical MED2005 in the Treatment of Erectile Dysfunction
Abstracts presented at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) report rapid absorption and onset of action with favorable short-term safety for female partners
Guildford, England - October 28, 2019 -- Futura Medical plc (AIM: FUM) (the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, today announced that data reported in two abstracts at SMSNA add to the growing body of data supporting the safety and efficacy of the Company's MED2005 topical gel for the treatment of erectile dysfunction (ED). In addition to demonstrating dose-proportional increases in penile blood flow following application of MED2005, the data also show that MED2005 has a good safety profile in female partners who are exposed to MED2005 through intercourse. SMSNA 2019 took place in Nashville, October 24-27.
While oral PDE5 inhibitors have provided significant benefits to many men with ED, these medications have limitations and up to half of patients discontinue treatment within 12 months of therapy initiation. Lorraine Grover, Psychosexual Nurse Specialist at The London Clinic explains "ED is often seen as strictly a male disease, but the condition often has a significant impact on partners' quality of life and can put additional pressure on partnerships. The data presented at SMSNA are encouraging and support the continued evaluation of MED2005 as a potential new ED treatment option for men who can't tolerate or don't respond to PDE5 inhibitors or who prefer a more rapid onset of action that enables greater spontaneity in their sexual relationships."
Current estimates suggest that ED disrupts the lives of at least one in five men globally, affecting the sexual and emotional health of approximately 27 million men and their partners in the United States alone. MED2005, a topical gel formulation of nitroglycerin applied directly to the penis by the male or his partner, works rapidly to help achieve and maintain an erection, and has significant potential as an innovative ED therapy that can overcome the medical and psycho-emotional limitations of PDE5i. A Phase 3 study is currently ongoing to assess the efficacy and safety of MED2005 at doses of 0.2-0.6% in 1,000 patients and their female partners.
"The data presented today add to the growing body of data supporting the clinical and commercial potential of MED2005," said James Barder, Chief Executive Officer of Futura Medical. "In previous studies MED2005 has been shown to significantly improve orgasmic function, intercourse satisfaction and overall satisfaction. Today's data provide evidence that these benefits may be achieved with a good partner safety profile. We believe that MED2005's fast-acting, topical formulation combined with the growing body of clinical evidence demonstrating efficacy and safety, make this innovative ED therapy an ideal alternative product. Additionally, these data further validate the broad potential of our DermaSys® advanced transdermal delivery system to enable novel treatment approaches that have improved safety and efficacy profiles compared with other modes of delivery."
SMSNA Data Presentations
Ultrasound Doppler Measurements of Penile Blood Flow as a Predictor of Clinical Efficacy1
(Abstract #114)
This placebo controlled, double-blind, dose ranging, crossover study evaluated the effect of escalating doses of MED2005 on erectile function as assessed by ultrasound Doppler measurement of blood flow within the penile cavernosal arteries. The study was conducted in 15 healthy, adult men and evaluated doses of 0.01, 0.075, 0.25 and 0.6 mg of MED2005. Significant differences in penile blood flow were noted only in the 0.6mg dose although 0.25mg showed some directional improvement. All doses were well tolerated and there was no clear evidence of headache as a drug related adverse event. No fall in blood pressure or symptoms associated with hypotension were reported. On this basis the 0.6mg (0.2%) dose was chosen for a Phase 2a) study.2 Results of that study demonstrate that ultrasound Doppler measurements of penile blood flow is a useful predictive Phase 1 pharmacodynamic tool in dose optimization, and correlates well with clinical efficacy.
Establishing the safety profile in sexual partners of a new topical nitroglycerin gel for the treatment of erectile dysfunction3
(Abstract #031)
This study evaluated the safety of MED2005 in female partners of 232 men who participated in a Phase 2a study.2 Adverse events were recorded in female partners following the application of 0.2% MED2005 (n=229) to the penis before intercourse. A 6-10 pharmacokinetic study was conducted to assess absorption of 0.8% MED2005 to the penis (n=10). Disruption of the epidermal membrane 2 hours after administration of MED2005 was evaluated on epidermal tissue from cadavers and compared with commercial lubricants. Results show that in over 1003 intercourse events, only 4 mild AEs in females were related to their partners' MED2005 treatment (two cases of headache and one case each of vulvovaginal pruritus and nasopharyngitis). Five minutes after application, an average of 27% of MED2005 remained on the penis, indicating absorption of 73% of the gel. Linear input rates predicted that virtually no MED2005 would remain on the penis 6-10 minutes after application. There was no significant difference between MED2005 and commercial lubricants on integrity of human epidermal membranes compared to KY warming (p=0.58) and Astroglide (p=0.30). The study authors conclude that MED2005 has a favorable short-term safety profile in female partners. Furthermore, the data suggest that MED2005 shows no increased potential for sexually transmitted infection risk in partners compared to commercial lubricants.
References
1. Holland T, James K, Ultrasound Doppler measurements of penile blood flow as a predictor of clinical efficacy. Abstract #114. Presented at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America. October 24, 2019.
2. Ralph DJ, Eardley I, Taubel J, Terrill P and Holland T. Efficacy and safety of MED2005, a topical glyceryl trinitrate formulation, in the treatment of erectile dysfunction: a randomized crossover study. J Sex. Med 2018;15:167-175.
3. Holland T, James K, Armstrong I, Establishing the safety profile in sexual partners of a new topical nitroglycerin gel for the treatment of erectile dysfunction. Abstract #031. Presented at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America. October 26, 2019.
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email: Investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
For US media enquiries please contact:
Lazar FINN Partners
Erich Sandoval, Media Strategist
Email: esandoval@lazarpartners.com
Tel: +1 212-867-1762
For European media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 950 9144
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology. These products are optimized for clinical efficacy, safety, administration and patient convenience and are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialization strategies are designed to maximize product differentiation and value creation whilst minimizing risk.
In a Phase II study for MED2005 announced in September 2016 the speed of onset of action of, partly reflecting the method of application with the gel being applied directly to the penis. 82% of patients with mild ED had an onset of action within 10 minutes and in 54% of mild ED patients onset was within 5 minutes.
The first European Phase 3 study for MED2002, referred to as "FM57", is a 1,000 patient, dose-ranging, multi-center, randomized, double blind, placebo-controlled, home use, parallel group study of MED2002 0.2%, 0.4% and 0.6% Glyceryl Trinitrate for the treatment of erectile dysfunction with an open label extension. FM57 is progressing on track, with headline data expected by the end of 2019.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com
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