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FDA Approves Jublia for Onychomycosis in Children

FDA Approves Jublia for Onychomycosis

The U.S. Food & Drug Administration (FDA) has recently approved a new use for Jublia (efinaconazole), a medication designed to treat a nail fungus condition called onychomycosis. This approval expands the age range indicated on the product’s label to include children aged six years and older. The announcement was made by Ortho Dermatologics, the dermatology division of Bausch Health Companies. In this blog, we’ll discuss the study and its findings. We’ll also talk about the treatment of toenail fungus in onychomycosis, how long the Jublia topical solution takes to work and other related things. Let’s get into it.

Approval of Jublia for Pediatric Onychomycosis Treatment

The Food and Drug Administration (FDA) has recently broadened the use of Jublia (efinaconazole) topical solution, allowing it to be used for treating toenail fungal infections (onychomycosis) in children as young as six years old. Previously, the medication was only approved for use in adults aged 18 and older.

Study Results Lead to Approval

The decision to expand the approval came after reviewing data from a phase 4 clinical study. This study was multicenter, open-label, and single-arm in nature and included 62 participants aged between 6 to 16 years. These participants had mild to severe onychomycosis of the toenails. The study’s main focus was on assessing the safety of Jublia over 52 weeks.

Additionally, for participants aged 12 to 16 years with moderate to severe onychomycosis, pharmacokinetics (how the drug moves through the body) was evaluated at four weeks. The study also looked at the effectiveness of the treatment, considering factors such as mycologic cure (elimination of the fungus), complete cure (completely clear nails and no fungus), and clinical efficacy (less than 10% toenail involvement).

By the end of the study, at week 52, it was found that 65% of the patients achieved mycologic cure, with a notable 36.7% achieving this as early as week 12. Furthermore, 40% of the patients experienced a complete cure, and 50% reached clinical efficacy by the end of the study.

Safety and Tolerability

In terms of safety, Jublia was well-tolerated among the participants, with ingrown nails being the most common treatment-related adverse event. Importantly, the drug’s systemic exposure in children was found to be comparable to that seen in adults, indicating a similar absorption and processing by the body.

Bill Humphries, the president of Ortho Dermatologics, highlighted the importance of this approval, stating, “Onychomycosis is increasingly being seen in pediatrics – representing 15 percent of all nail dystrophies in children.” He further added, “With nearly 6 years of real-world use since its initial approval to treat adults in 2014, Jublia has a demonstrated safety and efficacy profile, and we are pleased the FDA has recognized it as a valuable treatment option for children with toenail fungal infections.”

How Does Jublia Topical Solution Work?

Jublia is a topical solution specifically designed to treat toenail infections caused by fungi. It contains a key ingredient called efinaconazole, which belongs to a group of medications known as azole antifungals. Efinaconazole works by halting the growth of certain fungi, effectively treating the infection. It’s important to note that Jublia is only effective against fungal infections and will not work for infections caused by bacteria. Using this medication unnecessarily or too frequently can reduce its effectiveness.

One of the unique features of Jublia is its formulation, which has properties like low surface tension and a low tendency to bind with keratin. These characteristics help Jublia penetrate the nail and reach the site of infection when applied as instructed. For optimal results, Jublia should be applied once daily for a duration of 48 weeks, following your doctor’s instructions precisely. Establishing a daily routine for applying the medication can be helpful in ensuring consistent treatment. The time it takes for a healthy nail to grow back can vary from person to person.

What Is the Success Rate of Jublia?

The success rate of Jublia can vary based on how long you use it:

  • Over a period of 72 weeks, Jublia was successful in treating 57% of cases.
  • Around 11 months into daily treatment, 25% of users saw their nails almost or completely clear of infection.
  • In a different study, 15 to 18% of participants experienced a total cure of their nail fungus after using Jublia.

It’s important to remember that results can differ from person to person, and following your healthcare provider’s instructions is crucial for the best outcome.

Can You Use Jublia with Nail Polish?

Jublia (efinaconazole) and nail polish don’t mix well. Nail polish can block Jublia from getting into the nail bed, where it needs to be to fight the fungal infection. To make sure Jublia works, you should take off any nail polish before putting it on. While using Jublia, it’s best to skip pedicures and stay away from cosmetic nail products. Always check with a healthcare professional for advice. Jublia is only for use on the outside of the body, specifically for toenails and the skin right next to them. Remember, while you’re treating your nails with Jublia, hold off on pedicures and use nail polish or other nail cosmetics.

How Long Does It Take Jublia to Get Rid of Toenail Fungus?

Using Jublia (efinaconazole) for toenail fungus treatment typically requires a long commitment (longer time). It’s recommended to apply Jublia once daily for at least 48 weeks, which is roughly 11 months. However, it might take up to a year to see the full results. In clinical studies, more than half of the participants using Jublia tested negative for fungus after one year. It’s important to remember that results can vary from person to person, so make sure to follow your healthcare professional’s instructions carefully even when you want to buy Jublia from the best Canadian online pharmacy.


The FDA’s approval of Jublia for treating onychomycosis in children as young as six years old is a significant step forward in pediatric dermatology. This decision is backed by a comprehensive study that showed promising results in safety, efficacy, and tolerability. Jublia’s unique formulation allows for effective penetration into the nail, offering a viable solution for those struggling with toenail fungus. It’s crucial to adhere to the prescribed treatment regimen and consult with healthcare professionals for optimal outcomes. 

Remember, patience and consistency are key when using Jublia, as the treatment duration can be lengthy. By following the right approach, individuals can look forward to healthier nails and a reduction in fungal infections. This expanded approval marks a significant step forward in providing effective treatment options for children suffering from onychomycosis, offering hope for better management of this condition in the pediatric population.

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