Terbinafine Nail Solution - one step closer in the UK

Following from a previous post (click here) a number of colleagues have requested an update on a new drug which has completed phase three trials, which will have potential benefit in the UK for patients with onychomycosis. Here, I can provide a brief update following a recent announcement by a drug company.

 

Topical Terbinafine 10% nail solution is one step closer to being available in the UK.

Topical Terbinafine

Terbinafine has been available in the UK as a topical treatment for athletes foot since the 1990’s. Initially launched under the brand name of Lamisil, terbinafine has become a widely recognised drug in treating fungal skin and nail disease.

Terbinafine 1% cream / gel is widely available in the UK as a pharmacy (P) medicine and in larger sizes as a Prescription Only Medicine (POM). As a cream/gel, it is indicated in the treatment of tinea pedis.

For onychomycosis in the UK, currently only two topical medicines are available - Amorolfine 5% lacquer and Tioconazole Paint 28%.  The former being much more widely available in various pack sizes as a “P” pharmacy medicine for the treatment of mild to moderate onychomycosis, as most podiatrists will be aware.

Terbinafine has shown its benefit as an oral agent in treating fungal nail infection, and topically for skin infection (tinea pedis) but it has never been available as a licensed topical nail treatment. Following research and development work in Europe and North America, a new 10% topical terbinafine nail solution (MOB-015) has been developed and has completed clinical trials, showing a promising mycological cure rate of 69.9% [1]. Further details of this study are reported here.

The drug has now been commercially licenced from Moberg to Karo Healthcare AB, meaning it will be available in 19 European countries including the UK under the Lamisil brand (Press release here).

How long before we see terbinafine nail solution in the UK?

Although a commercial agreement is in place, the drug still has to be licenced for use in the UK through the appropriate agencies (MHRA) but it is one step closer to being available for patients in the UK. As soon as there is further news, I will update subscribers.

Reference

1.            Gupta, A.K., et al., Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild-to-moderate distal subungual onychomycosis: A randomized, multi-center, double-blind, vehicle-controlled phase 3 study. Journal of the American Academy of Dermatology, 2021. 85(1): p. 95–104.