Veregen

VEREGEN- sinecatechins ointment
PharmaDerm a division of Fougera Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

1.1 Indication

Veregen® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

1.2 Limitations of Use

The safety and effectiveness of Veregen® have not been established for treatment beyond 16-weeks or for multiple treatment courses.

The safety and effectiveness of Veregen® in immunosuppressed patients have not been established.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

Veregen® is to be applied three times per day to all external genital and perianal warts.

Apply about an 0.5 cm strand of the Veregen® to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Patients should wash their hands before and after application of Veregen®.

It is not necessary to wash off the ointment from the treated area prior to the next application.

Veregen® is not for ophthalmic, oral, intravaginal, or intra-anal use.

2.2 Treatment Period

Treatment with Veregen® should be continued until complete clearance of all warts, however no longer than 16 weeks.

Local skin reactions (e.g. erythema) at the treatment site are frequent. Nevertheless, treatment should be continued when the severity of the local skin reaction is acceptable.

3 DOSAGE FORMS AND STRENGTHS

Ointment, 15% w/w. Each gram of Veregen® Ointment, 15% contains 150 mg of sinecatechins in a brown ointment base.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

Veregen® has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions.

Use of Veregen® on open wounds should be avoided.

Patients should be advised to avoid exposure of the genital and perianal area to sun/UV-light as Veregen® has not been tested under these circumstances.

6 ADVERSE REACTIONS

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 Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.

Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women.

In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.

Local and regional reactions (including adenopathy) occurring at >1% in the treated groups are presented in Table 1.

Table 1: Local and Regional Adverse Reactions During Treatment (% Subjects)

Veregen®
(N = 397)

Vehicle
(N = 207)

Erythema

70

32

Pruritus

69

45

Burning

67

31

Pain/discomfort

56

14

Erosion/Ulceration

49

10

Edema

45

11

Induration

35

11

Rash vesicular

20

6

Regional Lymphadenitis

3

1

Desquamation

5

<1

Discharge

3

<1

Bleeding

2

<1

Reaction

2

0

Scar

1

0

Irritation

1

0

Rash

1

0

A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only.

Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle.

The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment.

Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia.

In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

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