Efinaconazole, sold under the brand name Jublia among others, is a

triazole antifungal An antifungal medication, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis (thrush), serious systemic infections such as crypt ...

medication. It is approved for use in the United States, Canada, and Japan as a 10% topical solution for the treatment of

onychomycosis Onychomycosis, also known as tinea unguium, is a fungal infection of the nail. Symptoms may include white or yellow nail discoloration, thickening of the nail, and separation of the nail from the nail bed. Toenails or fingernails may be affected ...

(fungal infection of the nail). Efinaconazole acts as a

14α-demethylase In enzymology, a sterol 14-demethylase () is an enzyme of the Cytochrome P450 (CYP) superfamily. It is any member of the CYP51 family. It catalyzes a chemical reaction such as: :obtusifoliol + 3 O2 + 3 NADPH + 3 H+ \rightleftharpoons 4alpha-meth ...

inhibitor Inhibitor or inhibition may refer to: In biology * Enzyme inhibitor, a substance that binds to an enzyme and decreases the enzyme's activity * Reuptake inhibitor, a substance that increases neurotransmission by blocking the reuptake of a neurotra ...

. It was approved as a

generic medication A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...

in the United States in 2020.

Medical uses

Efinaconazole is an

azole antifungal An antifungal medication, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis (thrush), serious systemic infections such as crypto ...

indicated in the US for the topical treatment of

of the toenails due to ''

Trichophyton rubrum ''Trichophyton rubrum'' is a dermatophytic fungus in the phylum Ascomycota. It is an exclusively clonal, anthropophilic saprotroph that colonizes the upper layers of dead skin, and is the most common cause of athlete's foot, fungal infectio ...

'' and ''

Trichophyton mentagrophytes ''Trichophyton mentagrophytes'' is a species in the fungal genus ''Trichophyton''. It is one of three common fungi which cause ringworm in companion animals. It is also the second-most commonly isolated fungus causing tinea infections in humans, ...

''.

Efficacy

In two

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

s 17.8% (trial 1) and 15.2% (trial 2) of participants using efinaconazole were completely cured (0% clinical involvement of the target toenail, plus negative

KOH test The KOH Test for ''Candida albicans'', also known as a potassium hydroxide preparation or KOH prep, is a quick, inexpensive fungal test to differentiate dermatophytes and ''Candida albicans'' symptoms from other skin disorders like psoriasis and e ...

and negative culture), compared with 3.3% (trial 1) and 5.5% (trial 2) of participants using a

placebo A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures. In general ...

. The "complete cure or almost complete cure" rate (≤5% affected target toenail area involved, and negative KOH and culture) for efinaconazole was 26.4% (trial 1) and 23.4% (trial 2) (compared with 7.0% (trial 1) and 7.5% (trial 2)).

History

In 2014, the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) approved the New Drug Application (NDA). According to Valeant Pharmaceuticals International Inc CEO

J. Michael Pearson J. Michael Pearson (born 1959) is a Canadian American pharmaceutical company executive. He is the former chairman and CEO of Valeant Pharmaceuticals International after being ousted in the aftermath of a report on pharmaceutical pricing publish ...

they acquired Jublia through their purchase of Dow Pharmaceutical Sciences in 2008. In 2020, the FDA approved a supplemental New Drug Application for efinaconazole topical solution, 10%, which extended the age range included in the product's label to children six years of age and older; it was first approved in 2014, in people aged 18 years of age and older.

Society and culture

Economics

In 2015, the cost of treatment with efinaconazole in the United States was said to be per nail. In 2019, a study by the

Canadian Agency for Drugs and Technologies in Health The Canadian Agency for Drugs and Technologies in Health, or CADTH, is a Canadian national organisation that provides research and analysis to healthcare decision-makers. The organisation was established in 1989 by the country's federal governme ...

found the cost for a 48-week course to be $178 for a big toe, and $89 for an other toe.

References

External links

* {{Portal bar , Medicine Fluoroarenes Lanosterol 14α-demethylase inhibitors Phenylethanolamines Tertiary alcohols Triazole antifungals