Berdazimer

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

• ZELSUVMI™ is indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ZELSUVMI™ is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.

• None. None.contraindicated

Dispense equal amounts from Tube A and Tube B per the dosing guide. ( 2.2 ) Mix together and immediately apply a thin layer of ZELSUVMI. ( 2.2 ) Apply once daily to each MC lesion for up to 12 weeks. ( 2.2 ) For topical use only and not for ophthalmic, oral, or intravaginal use. ( 2.2 ) 2.1 Important Preparation and Administration Instructions ZELSUVMI is supplied in a carton containing the following: Tube A containing berdazimer gel Tube B containing hydrogel Dosing guide Mix together equal amounts of gel from Tube A and Tube B before application [see Dosage and Administration (2.2) ] . Do not premix or store mixed ZELSUVMI. Instruct the patient to refer to the ZELSUVMI “Instructions for Use” for detailed instructions on the preparation and administration of ZELSUVMI [see Instructions for Use] . 2.2 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 ZELSUVMI as an even thin layer. Apply ZELSUVMI once daily to each MC lesion for up to 12 weeks. Wash hands after applying ZELSUVMI, unless hands are being treated. Allow ZELSUVMI to dry for 10 minutes after application. Avoid application to uninvolved skin and avoid transfer of applied ZELSUVMI to other areas, including the eye. Avoid swimming, bathing, or washing for 1 hour after application of ZELSUVMI. ZELSUVMI is for topical use only and not for ophthalmic, oral, or intravaginal use.

Application Site Reactions: Application site reactions, including allergic contact dermatitis, occurred. Discontinue ZELSUVMI and initiate appropriate therapy. ( 5.1 ) 5.1 Application Site Reactions Application site reactions, including allergic contact dermatitis, have occurred in patients treated with ZELSUVMI. Suspect allergic contact dermatitis in the event of pain, pruritus, swelling or erythema at the application site lasting longer than 24 hours. If allergic contact dermatitis occurs, discontinue ZELSUVMI and initiate appropriate therapy.

The most commonly reported adverse reactions (≥1%) are application site reactions, including pain (such as burning or stinging sensations, 18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LNHC, Inc. at 1-855-330-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In three double-blind, vehicle-controlled clinical trials (Trial 1, and Trial 2 and Trial 3, which were similarly designed to Trial 1), 1596 adult and pediatric subjects were treated with ZELSUVMI or vehicle gel topically once daily for up to 12 weeks [see Clinical Studies (14) ]. In these trials 3% of subjects were less than 2 years of age, and 96% of subjects were 2 to 17 years of age. The trial population included 51% male, 88% White, 6% Black, and 6% Other; for ethnicity, 21% of subjects identified as Hispanic/Latino, 78% as non-Hispanic/Latino, and 1% were not reported. Adverse reactions reported by ≥1% of subjects and more frequently than vehicle-treated subjects are listed in Table 1.

8.1 Pregnancy Risk Summary There are no available data on ZELSUVMI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of berdazimer to pregnant rats and rabbits increased malformations in the presence of severe maternal toxicity ( see Data ). The clinical relevance of this finding is unknown given the bioavailability of berdazimer following oral administration is significantly higher than topical application. The available data do not allow the calculation of relevant comparisons between the systemic exposure of berdazimer observed in animal studies and the systemic exposure that would be expected in humans after topical use of ZELSUVMI. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Systemic embryo-fetal development studies were conducted in rats and rabbits.

Metabolism

Plasma hydrolyzed MAP3 (hMAP3), a structural marker for berdazimer, and nitrate levels were evaluated in n=34 subjects 2 to 12 years of age with MC. Subjects applied ZELSUVMI once-daily for two weeks to a total treatment area of 484 cm 2 (mean lesion count=34), applying a mean dose of approximately 3 mL/day.

• Jan 5, 2024NDANDA217424Lnhc

The 10 most recently updated of 20 ClinicalTrials.gov registrations naming Berdazimer as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
  Completed · Phase 3 · Interventional · 1,330 enrolled · Novan, Inc.
  NCT02667444updated 2023-07-24
• P3 Study in Acne Comparing Once Daily SB204 and Vehicle
  Completed · Phase 3 · Interventional · 1,307 enrolled · Novan, Inc.
  NCT02672332updated 2023-07-24
• P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
  Completed · Phase 2 · Interventional · 213 enrolled · Novan, Inc.
  NCT02242760updated 2023-05-31
• P3 Long Term Safety Study of Once Daily SB204 in Acne
  Completed · Phase 3 · Interventional · 601 enrolled · Novan, Inc.
  NCT02798120updated 2023-05-12
• A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum
  Completed · Phase 2 · Interventional · 256 enrolled · Novan, Inc.
  NCT03436615updated 2023-05-06
• Topical NVN1000 for the Treatment of External Genital and Perianal Warts
  Completed · Phase 2 · Interventional · 108 enrolled · Novan, Inc.
  NCT02462187updated 2023-04-06
• A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC
  Completed · Phase 3 · Interventional · 355 enrolled · Novan, Inc.
  NCT03927703updated 2023-03-23
• A Phase 3 Molluscum Contagiosum Efficacy and Safety Study
  Completed · Phase 3 · Interventional · 891 enrolled · Novan, Inc.
  NCT04535531updated 2023-01-26
• A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
  Completed · Phase 3 · Interventional · 352 enrolled · Novan, Inc.
  NCT03927716updated 2022-12-27
• Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
  Completed · Phase 1 · Interventional · 60 enrolled · Novan, Inc.
  NCT01694810updated 2020-01-30

Frequently asked questions

How does Berdazimer work?

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

What is Berdazimer used for?

According to FDA labeling, Berdazimer carries indications including: ZELSUVMI™ is indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ZELSUVMI™ is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Berdazimer?

Berdazimer is classified as Unknown Cellular or Molecular Interaction, Increased Nitric Oxide Activity.

What are the brand names for Berdazimer?

Berdazimer is marketed under brand names including Zelsuvmi.

What are the contraindications for Berdazimer?

Berdazimer labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.