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This is the first study to assess the efficacy of 40% urea gel in combination with 8% ciclopirox lacquer.
Ciclopirox 8% solution is a lacquer formulation indicated for use in immunocompetent patients with mild to moderate onychomycosis without involvement of the lunula and due to T.
Weeks and his associates hypothesized that pretreatment with urea might thin and debulk thick, hyperkeratotic nails and thereby improve ciclopirox penetration into the nail plate.
These investigators tested free-drug concentrations--in suspensions prepared from keratin samples--of efinaconazole, ciclopirox, and amorolfine (similar to ciclopirox, amorolfine is an agent in a lacquer formulation; amorolfine is not FDA-approved).
Topical antifungal treatment with amorolfine 5% nail lacquer and ciclopirox 8% nail lacquer--which are not currently available in the United States but are available in most European countries--is effective as monotherapy in the treatment of white superficial onychomycosis and of distal subungual onychomycosis limited to the distal nail of a few digits.
MUNCICH -- Ciclopirox nail lacquer is a safe and effective therapy in diabetic patients with onychomycosis, Dr.
Patients with diabetes were not excluded from the pivotal trials of efinaconazole and tavaborole, but the disease was a cause for exclusion in the pivotal clinical studies of ciclopirox. In addition, the use of ciclopirox requires that patients keep their nails trimmed and that they follow up with their clinicians for regular removal of unattached, infected nails and debris; these activities potentially increase the risk for trauma and secondary infection, particularly in patients with diabetic neuropathy.
has won tentative approval for its ANDA for ciclopirox topical solution 8% (nail lacquer).
Drug Dosage Cost/Tube(*) Ciclopirox twice a day $31.83 (Loprox) clotrimazole twice a day $14.87 econazole once or $31.78 (Spectazole) twice a day ketoconazol once or $31.78 twice a day naftifine twice a day $31.73 (20g) (Naftin) $54.40(40g) terbinafine twice a day $58.40 (Lamisil) SYSTEMIC AGENTS Drug Dosage Cost/Tube(*) Terbinafine 250 mg/day $8.68 (Lamisil) itraconazole 200-400 mg/day $15.56 (200 mg) (Sporanox) TROPICAL AGENTS Drug [dagger]Comment Ciclopirox Pyradone, formulated as cream, gel, lotion, and topical (Loprox) suspension.
Maintenance with topical ciclopirox (Penlac) 2 days per week helps prevent relapse.
The specialty pharmaceutical manufacturer received clearance for ciclopirox cream 0.77%.
Among the first approvals the company has received this year are fluticasone cream and ointment, the generic equivalents of GlaxoSmithKline PLC's Cutivate; metronidazole cream, a generic version of Galderma Laboratories LP's MetroCream; and ciclopirox lotion, a generic equivalent to Medicis Pharmaceutical Corp.'s Loprox topical suspension.