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Penlac: Drug for Topical Treatment of Nail Fungus

Brand Name Drug: Penlac Nail Lacquer
Active Ingredient Drug: ciclopirox
Indication: Topical treatment of onchomycosis (nail fungus)
Company Name: Dermik Laboratories, a division of Aventis Pharmaceuticals
Availability: Approved by the FDA on December 27, 1999 and made available in the US in March 2000

Penlac Nail LacquerIntroduction

Millions of Americans, particularly those between the ages of 40 and 60, suffer from onchomycosis, a persistent fungal infection of the nails. It occurs when dermatophyte fungi, usually Trichophyton rubrum, invade the nail bed. Men and the elderly are afflicted most often, although the infection can strike all ages and women as well.

Onchomycosis of the toenails occurs four times more frequently than that of the fingernails, due in large part to the moist environment in shoes that promotes dermatophyte proliferation. In addition to causing embarrassment for its sufferers, onchomycosis can also cause discomfort and pain, particularly with walking, as the infection pushes up the infected nail. Nail fungus can lead to more serious infections in diabetics.

Until recently, such infections have been treated using oral preparations, such as terbinafine and itraconazole, but many patients cannot or prefer not to take these drugs. Penlac Nail Lacquer (ciclopirox) is now available in the US for these patients – the first topical agent approved in the US for this disorder. The lacquer was approved by the FDA on December 27, 1999 and made available in March 2000. Ciclopirox nail lacquer has been available for several years in Germany under the brand name Batrafen.

Manufactured by Dermik Laboratories, a division of Aventis Pharmaceuticals, Penlac is applied in the same manner as nail polish and should be used once daily, preferably at bedtime or eight hours before washing.

How It Works

Penlac Nail Lacquer Topical Solution 8% contains ciclopirox, a synthetic broad-spectrum antifungal agent that inhibits the growth of dermatophytes. In vitro studies suggest that ciclopirox may act by chelation of polyvalent cations, resulting in the inhibition of metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.

Penlac Nail LacquerPenlac Nail Lacquer (ciclopirox): Clinical Study Results

The efficacy of Penlac Nail Lacquer (ciclopirox) for the treatment of onchomycosis was established in two double-blind, placebo-controlled studies in the US. The research is expected to be published later this year. One study included 219 patients (study 312), while the other involved 235 patients (study 313); all patients had onchomycosis of the great toenails without lunula involvement. Patients were treated with either Penlac or placebo every day for 48 weeks, with monthly removal of the unattached, infected toenail by the investigators.

At 48 weeks, 5.5% of patients in study 312 and 8.5% of patients in study 313 who were treated with Penlac achieved a complete cure (defined as a clear nail with negative mycology), compared to 0.9% and 0% of placebo patients, respectively. The corresponding rates for an almost-clear outcome (10% or less nail involvement and negative mycology) were 6.5% and 12% for Penlac patients, compared to 0.9% and 0.9% for placebo patients, respectively. Negative mycology alone was achieved by 29% of the Penlac patients in study 312 and 36% of Penlac patients in study 313, compared to 11% and 9% of placebo patients, respectively.

What the Patient Should Know

The most common side effect reported by patients using Penlac was redness at the nail fold. Some patients reported a change in nail shape, ingrown toenail, and nail discoloration. Patients who experience signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) should inform their healthcare professionals. Penlac Nail Lacquer is for external use only.

Daily applications of Penlac should be made over the previous coat and removed with alcohol every seven days. Removal of the unattached, infected nail should be performed by a healthcare professional as frequently as monthly to obtain maximum benefit of the product. Patients should also trim their nails weekly. Six months of treatment may be required before initial improvement of symptoms is noticed; full treatment time may be as long as 48 weeks.

Patients should not use nail polish or other cosmetic nail products on nails treated with Penlac. Because no studies have been conducted to determine whether Penlac might reduce the effectiveness of systemic antifungal agents for onchomycosis, the concomitant use of Penlac and systemic antifungal agents is not recommended.

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