Summary of Cancellation for Terbylac
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal ingredient(s):
Terbinafine hydrochloride
Therapeutic area:
Antifungal
Type of submission:
New Drug Submission
Control number:
281005
Decision issued:
A Notice of Deficiency was issued.
Date of cancellation:
2025-04-14
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Terbylac (terbinafine hydrochloride topical solution, 10% w/w) nail lacquer. This submission was filed by Medexus Pharmaceuticals Inc. to seek authorization for Terbylac for the treatment of mild to moderate fungal infections of the nails caused by dermatophytes, and/or other terbinafine-sensitive fungi in adults.
What did the company submit to supports its submission?
The effectiveness of Terbylac was evaluated in a single pivotal phase III study and a supporting phase IIb study. The pivotal study was a multicenter, randomized, double-blind, parallel-group, vehicle-controlled with an active comparator open-label arm study to evaluate the efficacy and safety of terbinafine hydrochloride 10% nail lacquer in the treatment of onychomycosis. Based on the data provided, Health Canada considers that the criteria of substantial evidence of clinical effectiveness was not adequately demonstrated for terbinafine hydrochloride 10% nail lacquer. The data supporting Terbylac efficacy were limited with only one pivotal phase III study demonstrating the benefit of terbinafine hydrochloride 10% over the vehicle nail lacquer for the treatment of onychomycosis and unconvincing efficacy results from one phase IIb supportive study. Health Canada acknowledges Terbylac was statistically superior to the vehicle for the complete cure primary endpoint and the results were clinically relevant in the pivotal phase III study. However, a confirmatory study would be required to support the requested indication. Therefore, the limited data provided to show evidence of effectiveness is considered a deficiency precluding continuation of the review of this NDS, and a Notice of Deficiency (NOD) was recommended during review.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
At the time of the cancellation, the review of the submission was not complete. Health Canada had identified ongoing deficiencies in the data that would have precluded issuing an approval. The Sponsor chose to cancel their submission.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials. Other systemic products containing terbinafine hydrochloride are approved in Canada for treatment of onychomycosis caused by dermatophytes.
*Proposed Brand Name:
Terbylac
Manufacturer:
Medexus Pharmaceuticals Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2023-12-22