FDA Approves Olux for the BodyFirst posted Dec. 23, 2002
Connetics Corporation announced on Dec. 23, 2002, that the U.S. Food and Drug Administration (FDA) approved Olux Foam for use on the body. Olux was approved for treating scalp psoriasis in the fall of 2000. The approval extends the Olux label to include the short-term treatment of mild to moderate psoriasis in non-scalp regions, excluding the face and skinfold areas.
Olux is a foam formulation of clobetasol propionate, the most potent steroid available for the treatment of psoriasis. It is available by prescription.
How is Olux different from other topical treatments?
Olux may be more cosmetically appealing than other solutions, gels, lotions or ointments. The foam has the following benefits:
- does not stain
- is not greasy
- is easier to apply than solutions, gels, lotions or ointments
- is convenient because it can be used in multiple places on the body
The foam is designed to liquefy and absorb quickly. When it is applied to the skin, body heat causes the water and alcohol in the formulation to vaporize. The steroid is absorbed deep into the skin, leaving little residue.
Olux is similar to Connetics� other foam product Luxiq, which made its debut in April 1999 and contains a mid-potency steroid. Both products resemble styling mousse cans. In clinical studies, Olux proved slightly more effective than other clobetasol products for the scalp.
The new approval follows a clinical trial in January 2002 that showed significant improvement in people with mild to moderate body plaque psoriasis who used the medication. In the clinical trial, 279 patients at 17 clinical centers applied either placebo (inactive medication) or Olux twice a day for 14 days. Among patients treated with Olux, 67 percent had complete or almost complete clearance of psoriasis, according to the company.
What are the side effects?
Data from the trial is still being analyzed to determine whether there were significant side effects. In general, care should be taken when using powerful topical steroids. A risk is involved in abruptly stopping treatments with potent steroids like clobetasol propionate�plaque psoriasis can develop into pustular psoriasis, or, more often, it can worsen. Patients wishing to end treatment with steroids should talk with their health care provider about a regimen that gradually lowers doses.
What is the cost?
As of summer, 2002, Olux's wholesale price was $107 for 100 grams. Generally, retail price is 20 percent more. This makes Olux more expensive than other scalp-specific prescription medications that contain clobetasol propionate. Connetics believes the apparent cosmetic advantages of Olux will counteract the price for psoriasis patients. Also, patients will pay the same co-pay for the larger can of Olux as for the typically smaller can of other topicals, such as temovate.
Look for a full article on Olux in the new member publication early next year.
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