Zelsuvmi: A Novel FDA-Approved Drug for Molluscum Contagiosum.

Author- Dr. Md. Shamim, MD.

Introduction:

Zelsuvmi is a recent development in the field of dermatology. It has recently received FDA approval on dated 5^th January 2024 for the treatment of molluscum contagiosum. This contagious skin infection, commonly affecting children and adults.

Molluscum Contagiosum(MC):

• Molluscum contagiosum is a viral skin infection caused by the poxvirus.
• It is characterized by the appearance of small, raised bumps on the skin, often with a central indentation or white core.
• The infection spreads through direct contact or by sharing personal items such as towels or toys.
• While generally harmless, molluscum can be persistent and cause complications, especially for individuals with poor immune systems.

Mechanism of Action:

• ZELSUVMI is a nitric oxide releasing agent.
• The mechanism of action for the treatment of molluscum contagiosum is unknown.

Dosage forms:

• Topical gel: 10.3% berdazimer, supplied as two tubes.
• Tube A contains berdazimer gel and Tube B contains hydrogel.

Dosage and Administration:

• Dispense equal amounts from Tube A and Tube B per the dosing guide.
• Mix together and immediately apply as a thin layer.
• Apply once daily to each MC lesion for up to 12 weeks.
• For topical use only and not for ophthalmic, oral, or intravaginal use.

Recommended Dosage and Administration:

• Dispense equal amounts (0.5 mL) of gel from Tube A and Tube B on the dosing guide.
• Immediately put the caps back on Tube A and Tube B tightly.
• Mix together on the dosing guide.
• Immediately apply as an even thin layer.
• Apply once daily to each MC lesion for up to 12 weeks.
• Wash hands after applying drug, unless hands are being treated.
• Allow to dry for 10 minutes after application.
• Avoid application to healthy skin and avoid transfer of drug to other areas, including the eye, mouth,
• Avoid swimming, bathing, or washing for 1 hour after application of drug.
• It is for topical use only and not for ophthalmic, oral, or intravaginal use.

Indications and Uses:

• Approved for the topical treatment of molluscum contagiosum (MC) in adults and children over 1 year of age.

Adverse Effects:

Reactions on application site- most common:

• Pain (such as burning or stinging sensations)
• Erythema
• Pruritus
• Exfoliation
• Dermatitis
• Swelling
• Erosion
• Discoloration
• Vesicles
• Irritation
• Infection

Approval of Zelsuvm:

• Zelsuvmi is an advanced pharmaceutical formulation that has been specifically developed to treat molluscum contagiosum.
• After undergoing rigorous clinical trials and meeting the stringent criteria set by the FDA, Zelsuvmi has emerged as a safe and effective treatment option for patients suffering from this viral skin infection.

Clinical Efficacy and Safety:

• Extensive clinical trials have demonstrated the efficacy and safety of Zelsuvmi in treating molluscum contagiosum.
• Patients who participated in these trials experienced a significant reduction in the number and size of the lesions, leading to a visible improvement in their skin condition.
• Furthermore, Zelsuvmi has been proven to have a favorable safety profile, with minimal side effects reported during the trials.

Impact of Zelsuvmi on treatment of Molluscum Contagiosum:

• The approval of Zelsuvmi marks a significant milestone in the treatment of molluscum contagiosum.
• Previously, treatment options were limited, and the infection often resolved on its own over time.
• However, Zelsuvmi offers a targeted and effective solution that can expedite the healing process, providing relief to patients and reducing the risk of contagion.

Conclusion:

Zelsuvmi, the newly FDA-approved drug for molluscum contagiosum, brings hope and relief to individuals dealing with this viral skin infection. With its proven efficacy, safety, and targeted approach, Zelsuvmi is set to revolutionize the treatment landscape for molluscum contagiosum, improving the lives of countless patients. Always consult with a doctor to determine the most suitable treatment approach for your specific condition.

Reference:

Novel Drug Approvals for 2024.

Molluscum contagiosum.