Sciton's FDA Clears JOULE ClearSense™ for Onychomycosis
Sciton, a manufacturer of custom, modular, multi-application medical laser and light-based systems, has announced that the FDA has cleared its JOULE ClearSense for treatment of onychomycosis. The JOULE includes a versatile, laser delivery
technology with real-time temperature feedback for the safe and effective cosmetic improvement of dermatologic conditions including onychomycosis.
LEO
LEO Pharma Inc., a subsidiary of the makers of the Taclonex brand of topical treatments for plaque psoriasis, has launched the LEO Quality Care program to increase the usage of the Taclonex® treatments and to provide education materials and support to patients suffering from plaque psoriasis. Taclonex (calcipotriene and betamethasone dipropionate) Ointment, 0.005%/0.064% and Taclonex Scalp® (calcipotriene and betamethasone dipropionate)
Topical Suspension, 0.005%/0.064% are the only once-daily prescription, combination topical treatments for plaque psoriasis
and scalp plaque psoriasis, respectively, on the U.S. market.
The LEO Quality Care program features a starter kit that includes
a free sample of Taclonex Ointment or Taclonex Scalp Topical Suspension and a copay card for Taclonex products. For patients with private health insurance, the card may cover the entire insurance copay. For the uninsured, the copay card may cover up to $300 of the price of the products. Each card is valid for up to 6 prescription fills for Taclonex Ointment or Taclonex Scalp Topical Suspension. The card is valid until June 30, 2013.
Healthcare providers seeking to obtain Quality Care kits for their eligible patients can contact their LEO Pharma representative.
Patients who are already enrolled in the program will continue to receive updated materials, information and support from LEO Pharma Inc.
Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment is approved for use on the skin to treat psoriasis
vulgaris (plaque psoriasis) in adults 18 years of age and older and should be applied to affected areas once daily for up to 4 weeks. Taclonex Scalp (calcipotriene 0.005% and betamethasone
dipropionate 0.064%) Topical Suspension is approved to treat moderate to severe psoriasis vulgaris of the scalp in adults 18 years and older and should be applied to affected areas on the scalp once a day for 2 weeks or until cleared. Taclonex Scalp Topical Suspension may be continued for up to 8 weeks.
FDA Approves Pump Dispenser for Epiduo
Galderma Laboratories, L.P. has received approval from the FDA for a pump dispenser for Epiduo (adapalene and benzoyl peroxide)
Gel 0.1%/2.5%. This approval marks the first-ever pump dispenser for Epiduo Gel, the only once-daily, topical acne treatment
that combines two well-established active ingredients adapalene, a retinoid, and benzoyl peroxide, a well-known antimicrobial
with no evidence of promoting bacterial resistance, for patients aged 12 years and older.
Galderma cites studies that indicate that Epiduo Gel is more efficacious
than either of its components used alone and has had no evidence of promoting antibiotic resistance. Epiduo Gel simplifies
the management of acne and significantly reduces total acne lesions by approximately 18% as early as the first week of treatment. Epiduo Gel also helps to reduce the complexity of acne management by reducing the number of medications a patient has to remember to take on a daily basis, potentially increasing treatment adherence.
In addition, Galderma cites a recently completed randomized preference survey in which 92% of patients were satisfied or very satisfied with the new pump for Epiduo Gel. The survey, which ascertained patient preference for the Epiduo Gel pump over tube, involved 291 physician-diagnosed acne patients aged 12 to 35. The study found that nearly 80% of patients said
