Evaluating FMX-101 as a promising therapeutic for the treatment of acne

ABSTRACT

Introduction

Oral minocycline is a mainstay of therapy for moderate-to-severe acne; however, systemic side effects which include hepatotoxicity, lupus-like syndrome, drug hypersensitivity syndrome, autoimmune hepatitis, polyarteritis nodosa, gastrointestinal side effects and skin hyperpigmentation are of concern. Topical antibiotics commonly used in acne, such as erythromycin and clindamycin, present high P. acnes resistance rates which has opened the market for new topical antibiotics. FMX-101 is a novel topical minocycline foam that has shown promising results in phase I, II and III trials for the treatment of moderate-to-severe acne with a better safety profile than oral minocycline.

Areas covered

The author provides an overview FMX-101 including its clinical efficacy and safety. The author then provides their expert opinion on this treatment and its potential for the treatment option for acne.

Expert opinion

The topical foam formulation of FMX-101 has been shown to reduce both inflammatory and non-inflammatory lesions and to improve IGA scores in patients with moderate-to-severe acne without significant systemic absorption thus limiting associated side effects. Overall, the proven efficacy and safety profile of FMX-101, together with the low systemic absorption, high skin tolerability and cosmetically acceptable foam formulations render this novel therapy an important addition to the acne treatment armamentarium.

KEYWORDS:

• Acne vulgaris
• acne treatment
• topical acne therapy
• minocycline
• minocycline foam

Article highlights

• Four major factors have been implicated in the appearance of acne lesions: (1) altered sebum production, (2) abnormal keratinization within the pilosebaceous unit, (3) Propionibacterium acnes (P. acnes) colonization and (4) perifollicular inflammation.

• Current treatment guidelines recommend the use of systemic antibiotics in cases of moderate-to-severe acne. Tetracyclines, especially minocycline and doxycicline, are the antibiotics of choice because they not only limit P. acnes overpopulation but also have anti-inflammatory effects.

• However, systemic administration of minocycline is associated with serious adverse effects all of which could be limited by topical application.

• Topical minocycline foam FMX-101 4% has shown to be effective and safe in phase I, II and III clinical trials, without any systemic absorption of the drug, which could translate into better patient adherence.

• FMX-101 4% foam is a novel therapy that could be an important addition to the treatment of acne and an ideal alternative to oral antibiotics in patients with moderate-to-severe acne vulgaris.

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One referee declares that they are a consultant and researcher for Foamix and BioPharmX who develop the topical minocycline foam and gel, respectively. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This manuscript has not been funded.