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| Enstilar® - the First Combination Foam Spray for Psoriasis Launches in the UK | ||
| By: PR Newswire Association LLC. - 13 Jul 2016 | Back to overview list |
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HURLEY, England, July 13, 2016 /PRNewswire/ -- FOR DISTRIBUTION TO UK CONSUMER MEDIA ONLY (EXCLUDING REPUBLIC OF IRELAND AND MEDICAL MEDIA) The fixed-combination foam spray (calcipotriol/betamethasone dipropionate 50 micrograms/g + 0.5 mg/g) is more effective than other combination treatments for all severities of plaque psoriasis in adults People in the UK living with psoriasis now have a new treatment option with which to manage their condition. Enstilar® is the first psoriasis treatment available in a foam spray formulation for application to the skin, for use in adults.[1] It is available on prescription only. The launch of Enstilar® provides GPs and dermatology healthcare professionals with a new solution to support people living with psoriasis by helping them to regain control and live well with this chronic, life-impacting skin condition. The clinical data shows that it is a more effective topical combination treatment than those currently available and is generally well-tolerated.[2],[3] Additionally, in clinical trials, more than half of patients experienced significant visible signs of improvement after four weeks, and with some patients seeing improvements at one week.[4] "The launch of Enstilar® foam spray in the UK is a significant advance which provides an easy to apply topical combination treatment for plaque psoriasis, a distressing condition which affects up to 2 million people in this country. The fact that Enstilar® is more effective than other topical combination treatments and is generally well-tolerated means that individuals with psoriasis now have the chance to discuss with their GP or dermatologist whether this once-daily, foam spray may be an option that they should consider," commented Dr Keith Freeman, Consultant Dermatologist, Sunderland. The delivery system of the new foam spray provides a convenient treatment option for psoriasis patients,[2] ensuring the product is easy-to-apply.[2] It was developed to treat patients with plaque psoriasis[1] - the most common clinical form of psoriasis, affecting approximately 80% of psoriasis patients.[5] Impact on Quality of Life This treatment can also improve patients' quality of life (QoL).[6] 75% of patients feel that their quality of life is significantly impacted by psoriasis, both emotionally and physically.[6] 81% of psoriasis patients using Enstilar® foam spray in trials reported QoL improvements after four weeks,[7] with more than 70% seeing a reduction in itch-related sleep loss.[4] The symptomatic relief experienced by the majority of patients may be attributed to the cooling effect of the new foam spray.[8] "We are delighted that there is a new, effective treatment choice now available to treat plaque psoriasis, an area of significant unmet need," comments John Warne, Founder, Psoriasis Help Organisation. "Nearly 2 million people across the UK are living each day with the significant challenges of this chronic skin condition so we welcome new options to help them take back control." Adherence in Psoriasis Management - LEO Pharma's Solutions for Patients Adherence is a significant challenge for patients living with psoriasis (studies consistently suggest that up to 40% of people with psoriasis do not use their medication as directed).[9] In recognition of this challenge and to help patients achieve optimal outcomes, LEO Pharma has developed the below suite of new resources:
The launch of Enstilar® is an exciting landmark for LEO Pharma, which is committed to improving outcomes and quality of life for people living with skin conditions such as psoriasis," comments Geraldine Murphy, Managing Director of LEO Pharma UK & Ireland. "This is the first combination treatment of its kind and the foam spray delivery offers a convenient new treatment option. Insights from patients show that it will be easy and convenient to use, as well as being effective and generally well-tolerated. This could be a great advantage in improving treatment adherence, which can be such a challenge for people living with long-term skin conditions." Notes to editors Backgrounders on Enstilar® and psoriasis are available on request. Access to case studies and healthcare professionals' spokespersons for interview can be arranged. Regulatory Approval for Enstilar® The launch of Enstilar® foam spray in the UK follows findings in the positive regulatory review of the results of the pivotal Phase 3a PSO-FAST study,[4] which evaluated its efficacy and safety profile across a four week period, and the Phase 2 MUSE safety profile study.[3] In the PSO-FAST clinical trial, over half of patients treated with calcipotriol/betamethasone dipropionate foam spray were "Clear" or "Almost Clear" by week 4, as measured by the Physician Global Assessment (PGA) improvement score.[4] Additionally, more than half of patients treated with calcipotriol/betamethasone dipropionate foam spray achieved a 75% improvement in modified (excluding head) Psoriasis Area and Severity Index (mPASI) score from baseline after 4 weeks of treatment.[4] About Enstilar® Enstilar® (calcipotriol/betamethasone dipropionate) is a topical, alcohol-free, foam spray treatment for all severities of plaque psoriasis in patients who are 18 years or older.[1] It is designed to provide patients with a convenient treatment option that can be easily applied.[2] In clinical trials, the foam spray was generally well-tolerated[2],[3] and provided relief from psoriasis symptoms, including itch.[4] Patients treated with the new product in clinical trials experienced significant improvements in symptoms within the first week, and more than half achieved treatment success after four weeks.[4] About Psoriasis Psoriasis is a chronic, inflammatory skin disease, which is frequently accompanied by multiple physical and/or psychological comorbidities (the presence of one or more additional diseases), such as psoriatic arthritis, diabetes, cardiovascular disease and depression.[10] Psoriasis is estimated to affect up to 3% of the population of the UK.[11] 80% of patients are affected by plaque psoriasis - the most common type of psoriasis.[9] Topical treatments can be used as first-line therapies for the majority of patients living with psoriasis.[12] About LEO Pharma LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, the company supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to delivering products and solutions to people suffering from skin diseases. LEO Pharma is headquartered in Denmark and employs around 4,800 people worldwide. The UK/IE affiliate is headquartered in Hurley, Berkshire. For more information about LEO Pharma UK/IE, visit http://www.leo-pharma.co.uk. References 1. Enstilar® SmPC; UK. Available at: http://www.medicines.org.uk Last Accessed June 2016 2. Koo J, et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris - A randomized phase II study. Journal of Dermatological Treatment 2015; 1471-1753 3. Taraska V, et al. A Novel Aerosol Foam Formulation of Calcipotriol and Betamethasone Has No Impact on HPA Axis and Calcium Homeostasis in Patients With Extensive Psoriasis Vulgaris. Journal of Cutaneous Medicine and Surgery 2015; 1-8 4. Leonardi C, et al. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris - a Randomized Phase III Study (PSO-FAST). Journal of Drugs in Dermatology 2015; 14(12): 1468-77 5. American Academy of Dermatology. Psoriasis. Available at: http://www.aad.org/media/stats/conditions/psoriasis Last accessed June 2016 6. Leonardi C, et al. Improvements in health-related quality of life, and correlations with efficacy measures, with fixed combination calcipotriol plus betamethasone dipropionate aerosol foam (psoriasis PSO-FAST study. Poster 1722 presented at the 24th EADV Congress; Copenhagen, Denmark, 7-11 October 2015 7. Bhosle, M.J, et al. Quality of life in patients with psoriasis. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1501000/#B9 Last accessed: June 2016 8. LEO Pharma data on file: LEO90100 - 004 April 2016 9. Richards, HL. (2006), Adherence to treatment in patients with psoriasis, Journal of the European Academy of Dermatol and Venereology, 20 (4): 370-379 10. National Psoriasis Foundation. Comorbidities associated with psoriatic disease. Available http://www.psoriasis.org/about-psoriasis/related-conditions Last accessed June 2016 11. Psoriasis Association. About Psoriasis. Available https://www.psoriasis-association.org.uk/pages/view/about-psoriasis Last accessed June 2016 12. Psoriasis Association. Topical Treatments. Available http://www.psoriasis-association.org.uk/pages/view/about-psoriasis/treatments/first-line-treatments Last accessed June 2016 Job code: UK/IE/1070/00066 
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