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Valeant Canada introduces JubliaTM for the treatment of fungal infections of toenails
LAVAL, QC, July 22, 2014 /CNW Telbec/ - Valeant Canada is proud to announce the arrival of JubliaTM, an improved treatment for fungal infections of toenails. Onychomycosis affects 2.4 million Canadians - nearly 7% of the overall population.
More than just a cosmetic problem, these infections spread and are contagious. Though the signs can also appear on the fingernails, they are more common on the toenails where growth is slower, blood flow is reduced and the environment is dark and humid. These infections are recurrent and can result in serious complications such as permanent damage to the affected nail or even reduced mobility.
As effective as medicine taken orally, but much safer, JubliaTM is a topical solution containing efinaconazole, the most powerful antifungal agent on the market. The solution penetrates the nail at the desired location without accumulating in the body.
"With a similar efficacy, topical agents are a more beneficial option to treat nail fungus infections than oral treatments, which present serious risks of complication", says Bruce Ramsden, podiatrist and president of the Ontario Podiatric Medical Association.
JubliaTM (efinaconazole 10% topical solution) is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO). Being a solution, JubliaTM is applied daily to the nail and dries quickly. There are no concerns for systemic side effects such as drug-drug interactions or acute liver injury.
JubliaTM has been extensively studied prior to its approval. The two positive pivotal studies that were the basis for approval were published last year in the prestigious Journal of the American Academy of Dermatology. These international studies were conducted in 1,655 subjects with onychomycosis, including subjects in Canada.
For the pivotal studies, the primary endpoint was complete cure at Week 52, which required that the target nail show no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with JubliaTM were completely cured, compared to only 3.3% of subjects treated with vehicle. In Study 2, 15.2% of subjects treated with JubliaTM were completely cured, compared to only 5.5% of subjects treated with vehicle.
Adverse events that were reported were generally mild and transient and were similar between subjects treated with JubliaTM and vehicle. The most commonly reported adverse events in patients treated with JubliaTM were application site dermatitis and application site vesicles.
Onychomycosis is a common and destructive nail infection that is currently undertreated largely because of the limitations of available treatments. Currently, over-the-counter or prescription topical treatments provide limited efficacy and are often administered in conjunction with frequent debridement, or the scraping, cutting or removal of the nail. Prescription oral treatments are limited by drug interactions and serious safety concerns.
Onychomycosis is a common nail infection caused predominantly by dermatophyte fungi that typically occurs under the toenail, though fingernails may also be affected. The fungi that cause onychomycosis live in warm, moist environments, including swimming pools and showers, and may invade the skin through tiny cuts or small separations between the nail and nail bed.
The condition typically begins as a small white or yellow spot beneath the nail and causes nail discoloration, thickening and/or distortion, pain, detachment of the nail from the nail bed, and irregular surface changes. Once onychomycosis begins, it can persist indefinitely if not treated and may cause permanent nail damage. Currently, 85 percent of onychomycosis patients are untreated.
About Valeant Canada
Valeant Canada is a subsidiary of Valeant Pharmaceuticals International Inc., a multinational specialty pharmaceutical company that develops, manufactures, and markets a broad range of pharmaceutical products, primarily in the areas of dermatology, eye health, cardio-metabolics, neurology, and branded generics. More information about Valeant Canada can be found at www.valeantcanada.com.
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