A longstanding problem in the constantly changing field of dermatology is the age-old ailment known as molluscum contagiosum, which confounds medical professionals.

But in the midst of this ongoing battle, berdazimer has recently received FDA approval in January 2024, marking a significant development.

This recently approved remedy provides a ray of hope in the struggle against a disease that has afflicted people for generations.  

As doctors grapple with the complexities of Molluscum Contagiosum, the advent of berdazimer marks a pivotal moment in the ongoing battle against this ancient foe.

Understanding Molluscum Contagiosum

Molluscum contagiosum is a highly contagious infection brought on by the Molluscum contagiosum virus, a type of poxvirus.

It is an worldwide issue, although it appears to be more common in warm, humid climates.

The majority of patients diagnosed with molluscum contagiosum are two to five-year-old children, however it can also affect immunocompromised individuals, sexually active young people, and adults.

A benign, moderate skin illness with lesions (growths) that can arise anywhere on the body is typically the outcome of the infection.

Molluscum contagiosum usually clears up without leaving any scars in 6–12 months, although it might take up to 4 years.

Mollusca are small, elevated lesions that are typically flesh-colored, pink, white, or have a pit or dimple in the center.

They frequently resemble pearls. They are often solid and smooth. Lesions in most patients range in size from roughly the size of a pinhead to as big as the eraser on a pencil (2 to 5 mm in diameter).

This virus usually affects the face, trunk, and limbs of children and the abdomen, thighs, and genitalia of adults. Direct skin-to-skin contact with an infected person is how the virus is transferred.

Prior to berdazimer's clearance, molluscum contagiosum was treated with a variety of creative techniques.

It contained a medication that aggravates the sores, like benzoyl peroxide or retinoic acid. 

Cantharidin, a medication that removes the lumps, Freezing and Scraping (Cryotherapy).

One treatment option for those with compromised immune systems may be laser therapy.

About Zelsuvmi:

For the treatment of molluscum contagiosum (MC), Novan Inc., a Ligand Pharmaceuticals firm, developed Berdazimer topical gel, 10.3% (ZELSUVMI^TM), a topical gel that releases nitric oxide.

For the creation of berdazimer topical gel, 10.3%, Novan used their in-house developed NO-based technological platform (NITRICILTM), which stores gaseous NO species on massive polymers.

For the topical treatment of MC in adult and pediatric patients one year of age and older, berdazimer topical gel, 10.3%, was licensed by FDA for the use in USA.

Mechanism of Action

Nitric oxide is released by ZELSUVMI. There is no recognized mechanism of action for treating molluscum contagiosum. though it is understood how nitric oxide destroys viruses.

Nitric Oxide inhibits the reproduction of viruses, hence having particular antiviral effects at doses below those that are harmful to host cells.

The prevention of virus replication may be achieved through a broad process involving the nitrosylation of cysteine-containing proteins via NO.

It most likely affects a number of targets by nitrosylating viral structural proteins, blocking early and late viral protein synthesis, DNA replication, and RNA synthesis.

Under pathological situations (e.g., viral infection), reactive oxygen intermediates mediated reduced glutathione depletion has been documented, facilitating S-nitrosylation even though reductants (e.g., reduced glutathione) may restore the NO-induced oxidation.

It was demonstrated in one study that NO induced the infiltration of neutrophils, macrophages, and lymphocytes, as well as the expression of adhesion molecules such as vascular cell adhesion molecule 1 and intercellular adhesion molecule 1, as well as the migration of antigen-presenting cells.

Therefore, it's probable that NO promotes apoptotic cell death by causing DNA toxicity to infected cells.

Dosing and Administration:

The two parts of Zelsuvmi work together to encourage the release of nitric oxide (NO):

• Tube A- Berdazimer sodium, the nitric oxide donor

• Tube B- A hydrogel that promotes the regulated release of NO and functions as a proton donor on the skin.

A 10.3% berdazimer gel that is opaque and ranges from white to off-white. It contains 14 grams of berdazimer gel in Tube A (blue label) and 17 grams of hydrogel in Tube B (yellow label).

Equal amounts of gel should be dispensed from Tube A and Tube B onto the dosing guide. The mixture should be thoroughly combined.

It should be applied as an even thin layer immediately after mixing. It is recommended to apply it once daily to each Molluscum Contagiosum lesion for up to 12 weeks.

Safety Profile:

When using Zelsuvmi, be aware of possible serious side effects, including:

Allergic skin reactions, such as

• blistering

• swelling

• redness

• discomfort

• burning or stinging

• erosion of the skin's outer layer

• lighter or darker skin

• itchiness

• irritated skin

• peeling or flaking

• itchy skin rash

A research on berdazimer 10.3% gel for MC revealed that, for 16 of 34 patients, a total of 37 treatment-emergent adverse events (TEAEs) were reported.

Application site erythema and pain were the most commonly reported TEAEs, and both were primarily mild to moderate in severity.

Five patients had application-site scar TEAEs, all of which were deemed to have minor severity. No patient experienced hypertrophic or keloid scarring.

Only three individuals had severe TEAEs described; all of them had application-site pain, which was likely medication-related.

No significant TEAEs ,toxicity events that required stopping therapy, or fatalities occurred.10.3% of once-daily berdazimer gel was tolerated well according to the study.

Clinical Efficacy:

In a Three vehicle-controlled, double-blind clinical trials (Trial 1, Trial 2, and Trial 3,) involving 1598 participants (917 treated with berdazimer and 681 with vehicle), berdazimer demonstrated superiority over the vehicle with a complete clearance rate of 30.0% compared to 19.8% at week 12.

Subgroup analyses revealed consistent efficacy of berdazimer across various demographics and baseline characteristics.

Furthermore, berdazimer achieved satisfactory results for partial clearance, with mild to moderate erythema and application-site discomfort being the most common local skin reactions.

Overall, the study successfully met its primary endpoint of achieving complete clearance of all treatable MC lesions by week 12.

Zelsuvmi offers distinct advantages over traditional treatments for molluscum contagiosum. Its innovative formulation allows for easy self-application and localized release of nitric oxide (NO) precisely at the affected skin site.

By minimizing systemic exposure, Berdazimer reduces the risk of unwanted side effects commonly associated with other treatments.

Compared to invasive procedures like in-clinic curettage, cryotherapy, laser ablation, or chemical removal, it provides a convenient, non-invasive alternative for patients, enhancing overall treatment experience and effectiveness.

Zelsuvmi has some limitations including:

• Uncertain efficacy in cases of significant dermatitis, lesions close to the eyes, and sexually transmitted molluscum contagiosum (excluded from trials).

• Limited information available regarding molluscum contagiosum's safety and efficacy after 12 weeks of usage.

• It could take up to 12 weeks or more for the lesions to completely disappear.

For deeper insights into this topic, delve into the intriguing details provided in the drug label of Zelsuvmi.

Conclusion

Berdazimer represents a groundbreaking advancement in the treatment of Molluscum Contagiosum, offering a safe, effective, and convenient therapeutic option for patients.

With its unique mechanism of action, favorable pharmacokinetic properties, and promising study results, berdazimer stands poised to revolutionize the management of this common viral infection.

As we continue to unravel the mysteries of berdazimer, the future looks bright for patients seeking relief from Molluscum Contagiosum.