Vaniqa - eflornithine

Characteristics of the medicine

Vaniqa is a white cream containing 11.5% of the active ingredient eflornithine.

Therapeutic indications

Vaniqa is used in the treatment of facial hirsutism in women. Facial hirsutism is an overgrowth of facial hair, often with masculine characteristics.
The medicine can only be obtained with a prescription.

How to use

Vaniqa is applied in thin layers to the clean and dry affected area twice a day (at least eight hours apart) and massaged thoroughly. The benefit is noticeable within eight weeks of starting treatment. Continuous treatment can allow for further improvement and is necessary to maintain the beneficial effects. If no benefit is seen within four months of starting treatment, use of Vaniqa should be discontinued. Women using Vaniqa may need to use other means of hair removal (shaving, mechanical hair removal).

Mechanisms of action

Vaniqa contains the active substance eflornithine. Eflornithine blocks the action of an enzyme, ornithine decarboxylase. This enzyme is found in the bulb of the follicle from which it controls hair production. If the enzyme is blocked, hair growth is slowed.

Studies carried out

The efficacy of Vaniqa was evaluated in two clinical studies involving 596 women treated for up to 24 weeks with Vaniqa, or with placebo (a dummy treatment, in this case a cream with no active ingredient). At the end of the study, it was assessed the effectiveness of the treatment, with the following classification of hirsutism: "clear / almost clear", "marked improvement", "improvement" or "no improvement / worsening", 48 hours after the women had shaved the treated areas of the face and under the chin.

Benefits found following the studies

An improvement was observed as early as eight weeks after starting treatment. Both studies revealed significant improvement with Vaniqa compared to placebo. In 35% of the women treated with Vaniqa, compared with 9% of those treated with placebo, the results combined they revealed a favorable outcome (with a classification "clear / almost clear" or "marked improvement").

Associated Risks

The most frequently reported side effect (occurring in more than 1 in 10 patients) was acne. Other common side reactions are pseudofolliculitis (ingrown hairs), alopecia, prickling sensation, skin burning, dry skin, itching, erythema (redness), tingling, skin irritation, rash and folliculitis. For the full list of side effects reported with Vaniqa, see the package leaflet.
Vaniqa must not be used in people who may be hypersensitive (allergic) to eflornithine or the other ingredients of the medicine.

Reasons for approval

The Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Vaniqa for the treatment of hirsutism in women are greater than its risks. of medical personnel) for Vaniqa.

Further information

On March 20, 2001, the European Commission issued a "marketing authorization" valid throughout the European Union for Vaniqa. The holder of the "marketing authorization" is the company Laboratorios Almirall, S.A.
For the full version of the Vaniqa evaluation (EPAR), click here.

Last update of this summary: August 2008

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