Live Blog: Valeant Pharmaceuticals Product Theater – Acanya Gel and Solodyn Tablets
In this live blog from the 12th Annual SDPA conference in Indianapolis, Dr. Charles Hudson and Valeant Pharmaceuticals presented a Product Theater with Breakfast on Acanya Gel and Solodyn Tablets. Here are some of the highlights.
Some facts about acne:
– Acne affects approx. 40-50 millions individuals in the US alone.
– Nearly 85% of adolescents and young adults between ages of 12 – 24 develop acne.
– Clinical presentation and morphologic evidence of acne varies.
– Acne is more common in boys than girls during adolescence but incidence is higher in women during adulthood.
Valeant has had a focus on creating innovative vehicles. Acanya Gel was created with 4 goals in mind:
Goal 1: once daily application
Goal 2: elegant aqueous gel formation that contains no surfactants, preservatives or alcohol
Goal 3: efficient delivery of benzoyl peroxide into the skin
Goal 4: formulated with tolerability in mind; Valeant reduced the previous benzoyl peroxide from 5% to 2.5% in order to reduce irritation.
Acanya Gel is a lincosamide antibiotic and bactericidal/keratolytic combination product indicated for the topical treatment of acne vulgaris. It is available in a ready-to-use 50g pump. It’s combination therapy reduces potential for antibiotic resistance.
In Phase 3 Pivotal Studies:
The objective was to evaluate efficacy, safety and tolerability of clindamycin and benxoyl peroxide gel against individual active ingredients and vehicle treatment of patients with moderate to severe acne. Participants were admitted to the study if they had 17-40 inflammatory lesions total and 20-100 facial non-inflammatory total (moderate to severe acne patients).
– 2813 male and female subjects
– 12 to 70 years of age
– One daily application for 12 weeks.
– Baseline 4, 8, 12 week check-ins
Most common local adverse reactions experienced by patients in clinical trials were mild and moderate erythema, scaling, itching, burning, and stinging. 97% of adverse drug reactions were rated as mild to moderate in severity and application site reactions in the Acanya group were rare (0.1%).
Acanya is the only FDA approved clindamycin/BPO fixed combination dosed once daily in the treatment of moderate to severe inflammatory and non-inflammatory acne vulgaris. Acanya Gel demonstrated statistically significant efficacy compared to individual active ingredients and vehicle at week 12.
Common managed care barriers to treatment of acne vulgaris:
– overwhelming number of phone calls
– prior authorizations
– step edits not covered
– drain on staff time and resources
– repetitive faxes from pharmacies
In order to help remove care barriers Valeant has created the Acanya Access Passport to help patients get access to Acanya Gel.
Solodyn “A Clear Path to Clearer Skin”
Solodyn is a minocycline formulation that delivers low, steady state levels of medication.
Solodyn is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Solodyn did not demonstrate any effect on non-inflammatory lesions. Safety of Solodyn has not been established beyond 12 weeks of use.
The targeted dose range for Solodyn tablets is 1 mg/kg/day for patients with non-nodular, moderate to severe inflammatory acne
In clinical trials of the 45 mg, 90 mg, and 135 mg strengths with 1,038 patients, Solodyn demonstrated efficacy in a low dose (1 mg/kg/day). There was no evidence of improved efficacy with 2 mg/kg/day and 3 mg/kg/day. Higher doses of Solodyn have not been shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular adverse events. Clinical studies also showed that SOLODYN tablets were well tolerated, with an adverse event profile similar to placebo.
The most commonly observed adverse reactions are headache, fatigue, dizziness, and pruritus. Minocycline, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman. Tetracycline drugs should not be used during tooth development (last half of pregnancy and up to 8 years of age) as they may cause permanent discoloration of teeth.
In order to help remove care barriers Valeant has created the Solodyn Access Passport to help patients get access to Solodyn tablets.