Press Release – Lipidor gets go-ahead for Phase III Clinical Study of new Calcipotriol Spray treatment for psoriasis
India’s CDSCO (Central Drugs Standard Control Organization) has approved Phase III Trials of a new topical anti-psoriatic spray developed by Swedish company Lipidor. The new spray is expected to overcome patient non-compliance, a major problem for traditional psoriasis creams and ointments. It is exceptionally fast-drying and easy to apply. Calcipotriol Spray consists of the generic Vitamin D analogue, Calcipotriol, formulated in Lipidor´s patented lipid-based drug delivery technology, AKVANO®. Lipidor has developed the clinical trial material (CTM) in cooperation with Swiss API supplier Cerbios-Pharma SA, while Cadila Pharmaceuticals, one of India’s largest privately held pharma companies, is responsible for the clinical phase III study. The study will be carried out at 13 centers in India, with 266 patients with mild to moderate psoriasis.
Increased comfort = increased compliance
Non-compliance has been a major problem for topical psoriasis treatments. Creams and ointments being sticky or greasy, and unpleasant or time-consuming to apply have all been frequently reported by patients as reasons to stop taking treatment.
Calcipotriol Spray delivers an exceptionally comfortable experience to patients, drying cleanly and very quickly on the skin, compared to ointments, creams and gels.
The active ingredient is the generic Vitamin D analogue Calcipotriol, which reduces psoriasis symptoms by reducing excessive skin cell production. Calcipotriol Spray contains no steroids, and is formulated with AKVANO®, Lipidor´s patented lipid-based drug delivery technology based on skin barrier enforcing lipids.
Olle Holmertz, Lipidor AB Acting CEO: “We are delighted to get the green light to begin Phase III trials of this important new treatment. Combining efficient pharmaceutical delivery with excellent cosmetic qualities and improved comfort and convenience, we believe Calcipotriol Spray is a truly global medical opportunity, treating a condition, psoriasis, which affects 2-3% of the world’s population.”
Dr. Rajiv Modi, CMD, Cadila Pharmaceuticals Ltd., said: “We are driven by research-based innovations that provide care and affordable solutions to our customers. Our partnership with Lipidor will help to bring forward a superior solution for psoriasis which will ensure greater compliance and efficacy.”
AKVANO® and Calcipotriol Spray are protected by granted patents and patent applications. Lipidor will be looking for licensing partners for all countries for registration and market introduction of Calcipotriol Spray.