Terbinafine

ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines ·
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Articles

Medicine Compliance Aid Stability

LamisilNovartis Pharmaceuticals UK Ltd

Novartis Pharmaceuticals UK Ltd
Lamisil
Tablets 250mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from light.
13 July 2015

Lactation Safety Information

Oral

Oral
Fluconazole
Limited published evidence of safety
Doses of 500mg daily have produced low levels in milk
Monitor infant for jaundice and other signs of liver toxicity
Monitor infant for gastro-intestinal disturbances, especially if used for prolonged periods or in high doses, although unlikely to occur.
10 November 2020

For topical use

For topical use
17 September 2020

New Medicines

Onychomycosis - transungual film-coating laquer solution

Information

New formulation
Almirall
Almirall

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase III Clinical Trials
Nov 19Terbinafine (ALM12834) has been submitted to the EMA for topical treatment of onychomycosis [6,7].
Mar 19Polichem is a subsidiary of Almirall [5].

Category

Broad spectrum allylamine antifungal agent, formulated with a hydroxypropyl chitosan excipient for better penetration into nails.
This is one of the most commonly occurring dermatological conditions. International prevalence reports a range from 3-26% worldwide. UK prevalence studies report a range of 3-8%. The incidence of new cases of onychomycosis appears to be rising due to the increasing prevalence of diabetes in the population, more frequent incidence of immunosuppression and an ageing population [1].
Onychomycosis - transungual film-coating laquer solution
Topical

Trial or other data

Sep 18The PIII (NCT02549001) study that evaluated the safety and efficacy of 10% terbinafine nail lacquer for onychomycosis has completed. Results are awaited [4].
Jan 18Polichem (a subsidiary of Almirall) has withdrawn a PIII trial (NCT03094468) for Onychomycosis in the US and Canada prior to enrolment, due to change in priorities in project development [4].
Sep 17PIII (NCT02549001) study has completed recruitment. Collection of primary outcome data is due to complete Oct 18 [3].
Sep 17PIII trial that investigated tolerability of terbinafine nail lacquer in children with mild-to-moderate distal subungual onychomycosis completes (NCT02547701). Patients received a 10% dosage applied once-weekly, and the primary endpoint was local tolerability at the application site, assessed by the Severity Score for Skin Irritation. The trial enrolled 20 patients aged 2 to 17 years, in Belgium, Germany, Italy, Latvia and Spain [2].
Jun 15PIII study to evaluate safety and efficacy of 10% terbinafine nail lacquer for treatment of onychomycosis starts (NCT02549001). Enrolment of approximately 840 patients, aged 12 to 80, is underway in Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary, Latvia, Lithuania, Poland, Slovakia, Russia, Sweden & the US [2].

Onychoycosis - topical formulation

Information

New formulation
Bayer
Moberg Pharma

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Antifungal, developed using technology which enables high concentrations of the compound to penetrate the nail tissue. Clinical development of a suspension formulation and an improved, solution formulation (MOB 015B) is underway
This is one of the most commonly occurring dermatological conditions. International prevalence reports a range from 3-26% worldwide. UK prevalence studies report a range of 3-8% in the UK. The incidence of new cases of onychomycosis (OM) appears to be rising due to the increasing prevalence of diabetes in the population, more frequent incidence of immunosuppression and an ageing population [1].
Onychoycosis - topical formulation
Topical