FDA Approves Jublia for Fighting Nail Fungus

Two new topical prescription drugs have been approved by the FDA for the treatment of nail fungus. Last month, the agency gave the green light to a drug called Jublia (efinaconazole). This month, the FDA approved Kerydin (tavaborole) which is also applied directly to affected nails.

It is estimated that over 30 million Americans suffer from toenail fungus, which leads to thickening, yellowing and discomfort. Oral antifungal drugs are available by prescription but have worrisome side effects and frequently interact with other medications.

The new topical agents were applied daily for 48 weeks and evaluated after one full year. Jublia resulted in a complete cure of nail fungus in 15 to 18 percent of study subjects. Daily use of Kerydin resulted in cure for 6.5 to 9 percent of study subjects. Both products have potential side effects such as redness, itching, swelling or irritation of the toes, but because they are applied to the nails and nail beds, they are not expected to affect the liver or interact with other drugs. One possible complication of Jublia is ingrown toenails. According to the prescribing information, that occurred in 2.3% of those applying the drug.

Are you impressed with these cure rates? We aren’t, either. A complete cure rate of 15 to 18 percent after almost a year is hardly something to write home about. And wait till you hear the price. We checked with one of the largest  drugstore chains in the country. In our area, a 4 ml bottle of Jublia would cost $539. You read that right! Mind boggling, eh? That works out to $135 per ml. It is not clear that insurance will cover the cost.

You are supposed to apply one drop per affected toenail. If the big toe is affected, you will need two drops. So, if you have two toenails plus a big toe infected with fungus, you will need 4 drops per day. There are roughly 20 drops in a milliliter or 80 drops in a 4 ml bottle. That means you will go through one 4 ml bottle in about three weeks. But wait, the treatment is supposed to continue for 48 weeks. That means you would need 16 bottles. If you multiply 16 x $539 you end up with a total cost of $8,624. Without insurance, this would be prohibitive. And remember, the complete cure rate is at best 18% after 48 weeks.

There are advantages of a topical liquid antifungal agent over an oral medicine. There are far less serious side effects, for one thing. But if you are interested in topical treatments, you may want to consider a home remedy first. We can assure you that the cost will be infinitesimal compared to a prescription product like Jublia.

To learn more about home remedies and some older, less expensive ways of treating nail fungus, you may be interested in our Guide to Hair and Nail Care. Read other comments below or add your own.