The dermatological antifungal segment has three more FDA approved options. This is good news for a specialty area that could use more diversity when it comes to treating fungal infections. Tavaborole and Efinaconazole were both approved by the FDA in 2014 to treat fungi of the nail and nailbeds, and Crisaborole was approved in 2016 by the FDA to treat atopic dermatitis (or the most common form of eczema.)
Tavaborole works to inhibit the fungal enzyme leucyl-tRNA synthetase in the case of onychomycosis, a fungus of the nails. This drug entered its Phase III trials at the end of 2010 before finally meeting FDA approval in 2014. It’s used to block additional fungal growth before killing off the fungus entirely. During clinical trials, tavaborole was shown to be more effective than standard ethyl acetate and propylene glycol combinations. The fungal infections were eliminated at 6.5% to .5% in one study, and 27.5% to 14.6% in another study. It was developed as a topical therapy because many patients object to the duration and the side effects of standard oral therapies.
Efinaconazole is another topical method to treat those with nail fungus, and it’s the first topical triazole treatment for onychomycosis. In clinical studies, it was able to cure the fungus at rates of 17.8% against the 3.3% placebo in one study and 15.2% against the 5.5% placebo rate in another study. Efinaconazole works by preventing the production of ergosterol, a key component in the cell membranes of fungi. This treatment was designed to help those with mild nail fungus (usually marketed in the public sphere for toenail fungus) or for those who cannot take an oral treatment.
Unlike Tavaborole and Efinaconazole, Crisaborole was developed as a means to treat atopic dermatitis and psoriasis. It works by stimulating the immune response to control the inflammation of the skin, thereby reducing and eliminating skin irritation. By using a boron atom, it appears to suppress or prevent the releasing of the cytokines that trigger the aggravation. Crisaborole was deemed safe for long-term use after a 48-week study conducted at the Rady Children’s Hospital in San Diego.
A New Frontier
All of these dermatological antifungal APIs safely treat common conditions in a growing market. The onychomycosis market in the US is expected to grow exponentially due to the aging population as well as an increase in diabetic patients. Statistics on this condition are difficult to ascertain due to a lack of awareness for nail fungus, but public education efforts are expected to increase over the next few years. If left untreated, onychomycosis can lead to nail loss.
Both Tavaborole and Efinaconazole work to cure the fungus without the need for oral medication (which is usually the first line of defense.) The oral medications for fungus come with a laundry list of side effects, including jaundice if taken by those with liver conditions. People may experience everything from nausea to dizziness, even after they’ve finished the recommended dosage. Lamisil, for example, stays in the body for six months after completion.
Crisaborole can be used to help the 28 million people who suffer from atopic dermatitis in the US alone. If it’s found to be successful for psoriasis, it could potentially help up to 3% of the world’s entire population. It was proclaimed to be the first new agent in the past 15 years to treat the condition because it wasn’t a standard corticosteroid or calcineurin inhibitor. Instead, Crisaborole takes a targeted approach to mitigate the negative symptoms of atopic dermatitis. It’s not a corticosteroid, meaning it won’t cause a loss of skin pigment, spider veins, or atrophy in the user.
In short, all three of these dermatological antifungal APIs show promising results to give new life to a field that desperately needs more attention.
About LGM Pharma
As the dermatological field continues to expand with new research and technologies, you can expect LGM Pharma to be front and center in delivering APIs to the right hands. LGM is dedicated to being at the forefront of a wide variety of effective APIs. It’s why we specialize in supplying new and difficult to obtain pharma ingredients to our distributors. It’s our goal to offer a wide range of effective ingredients for all our clients, which is why we cover all major therapeutic classifications. Our API portfolio comes complete with all necessary documentation, including DMFs, ASMFs and CEPs available. LGM Pharma has extensive experience with a number of new formulation developments, drug delivery systems, and interesting technology platforms. By having all the right resources at our fingertips, we can continue to provide APIs as effectively as our clients need them.