FORT WORTH, Texas, Jan. 17 /PRNewswire/ -- Galderma Laboratories announced today the launch of its CLOBEX(R) (clobetasol propionate) Spray, 0.05% in a larger 4.25-fluid-ounce bottle for the treatment of moderate-to-severe plaque psoriasis. Now available by prescription in both a 2-fluid-ounce and 4.25- fluid-ounce bottle, CLOBEX(R) Spray is the only available super-high potency corticosteroid formulation(1) that couples the proven strength of clobetasol in a highly-convenient, patented spray formulation.
According to a study published in the November issue of CUTIS, CLOBEX(R) Spray was demonstrated to be safe and effective in a recent multicenter, randomized, double-blinded, vehicle-controlled, parallel-group, comparative study in subjects with moderate to severe plaque psoriasis. Subjects were randomized to receive either clobetasol propionate spray 0.05% (n=60) or vehicle spray (n=60) twice daily for 4 weeks, followed by a 4-week treatment- free follow-up period. The additional 2 weeks of treatment from weeks 2 to 4 increased the number of clear and almost clear subjects from 55% to 78%(2); treatment success was still in favor of clobetasol propionate (P<.001) at week 8 (4 weeks post treatment). Forty-four percent of subjects were clear or almost clear without receiving any medication(3). Overall, clobetasol propionate spray 0.05% administered twice daily for 4 weeks was effective and safe in reducing scaling, erythema, plaque elevation, and overall disease severity and demonstrates durable clinical response up to 4 weeks after treatment end.
This launch of CLOBEX(R) Spray 4.25-fluid-ounce is yet another testament to Galderma's ongoing commitment to meeting patient needs. The company recently supported the National Psoriasis Foundation's College-Age Psoriasis Awareness Campaign (CAPAC) directed to educating young adults ages 18 to 25 about the physical, emotional and social impact of psoriasis. CAPAC showcased the "Psoriasis 101: Learning to Live in the Skin You're In" brochure that is available free-of-charge by visiting www.psoriasis.org or calling 800.723.9166.
"Clobex(R) Spray's unique indication for up to four weeks of treatment and up to 20% BSA affected has made the larger 4.25-ounce bottle a necessity for patients who wish to remain totally compliant to their treatment," said Albert Draaijer, President, Galderma Laboratories, L.P. "The availability of the 4.25-ounce bottle will help better ensure that patients have an adequate supply of the convenient, easy-to-use therapy to consistently manage the non- contagious, common and chronic disease."
Twice-daily CLOBEX(R) Spray should be applied directly on the lesion(s), avoiding the surrounding skin. Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. In controlled clinical trials the following adverse reactions have been reported: burning, pruritus, dryness, pain, hyperpigmentation around resolving plaque, irritation and atrophy. CLOBEX(R) Spray is not recommended for use on anyone younger than 18 years of age. The total dosage should not exceed 50 g (59 mL or 2 fl oz) per week. Patients should use CLOBEX(R) Spray, 0.05%, only for the minimum period necessary to achieve desired results.
CLOBEX(R) Spray reflects the proven and well-known clinical profiles of CLOBEX(R) Lotion and Shampoo. Available by prescription since September 2003 and June 2004 respectively, CLOBEX(R) Lotion and Shampoo are clinically proven to reduce and/or eliminate the signs and symptoms of moderate-to-severe psoriasis.
About Psoriasis
Psoriasis is a common chronic skin disease that comes in different forms and varying levels of severity. More than 4.5 million adults in the U.S. have psoriasis with nearly half of all patients experiencing the condition on their scalp. Psoriasis generally appears as patches of raised red skin covered by a flaky, white buildup, and is typically accompanied by intense itching and burning. Certain types of psoriasis can also produce a pustular appearance. With psoriasis accounting for an alarming 1.7 million patient visits in 2003 alone, these numbers are expected to grow.
About Galderma
Galderma is one of the world's leading specialty pharmaceutical companies, focused exclusively on research, development and marketing of dermatology products. The company deploys a worldwide network of 33 fully owned subsidiaries with products marketed in more than 70 countries. Galderma Laboratories, L.P. is the United States subsidiary of Galderma worldwide.
To learn more about Clobex(R) Spray, please visit www.clobex.com (1) First DataBank; Updated: 10/6/2006 (2) Phase III, Study I, Table 3.1 (3) Phase III, Study I, Table 4.6.1
GaldermaCONTACT: Vicki Vlastaris, +1-646-437-4873, or vvlastaris@gsw-w.com, forGalderma
