ALDARA® (imiquimod) Cream, 5% demonstrated a reduction in lesion size in patients with vulvar intraepithelial neoplasia (VIN)
A study published in the April 3, 2008 issue of The New England Journal of Medicine concludes that imiquimod cream, 5% (Aldara) “is a promising agent for the treatment of vulvar intraepithelial neoplasia.” Vulvar intraepithelial neoplasia (VIN) is a pre-cancerous skin lesion of the vulva often caused by human papillomavirus (HPV). According to the authors, patients treated with Aldara did not experience certain side effects or limitations commonly associated with surgery, the most frequent treatment for VIN.
In a randomized study comparing imiquimod cream, 5% (Aldara) to placebo in 52 patients with grade 2 or 3 VIN lesions, a reduction in lesion size by more than 25% was demonstrated in 81% of patients treated with Aldara and in no patients treated with placebo at 20 weeks. (P<.001). Lesions completely cleared in 34% of Aldara-treated patients and an additional 19% of patients experienced a reduction in lesion size greater than 75%. All 9 patients who were completely clear at 20 weeks remained clear at 12 months. Four of these 9 patients had 2 or 3 surgeries for VIN before being treated with Aldara. About Vulvar Intraepithelial Neoplasia (VIN) VIN is a preinvasive squamous cell carcinoma (carcinoma in situ) similar to cervical intraepithelial neoplasia (CIN) or dysplasia. VIN is caused by HPV infection. Surgical removal of lesions is the treatment of choice, but has limitations, including poorly defined surgical margins, disfigurement of the vulva, and recurrence because surgery does not remove HPV. About ALDARA Aldara Cream is not FDA-approved for the treatment of VIN. ALDARA is the brand name for imiquimod, which is an immune-response modifier. Aldara Cream is a skin-use only (topical) medicine used to treat external genital and perianal warts/condyloma acuminata in patients 12 years old or older. Safety and efficacy of ALDARA Cream in immunosuppressed patients have not been established. The most common side effects are application site reactions or local skin reactions: itching, burning, redness, flaking/scaling/dryness, scabbing/crusting, edema, peeling, skin that becomes hard or thickened, erosion, and ulceration. Most skin reactions are mild to moderate in nature. 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 trial of another drug and may not reflect the rates observed in practice. The effect of Aldara Cream on the transmission of external genital warts is unknown. Aldara Cream may weaken condoms and diaphragms. Sexual contact should be avoided while the cream is on the skin. New external genital warts may develop during treatment. About Graceway Pharmaceuticals, LLC Graceway Pharmaceuticals, LLC ("Graceway"), headquartered in Bristol, TN, is a pharmaceutical company focused on acquiring, in-licensing, and developing branded prescription pharmaceutical products. Current prescription products marketed by Graceway include ALDARA® (imiquimod) Cream, 5%, Maxair® Autohaler® (pirbuterol acetate inhalation aerosol), Atopiclair® Nonsteroidal Cream, and Estrasorb® (estradiol topical emulsion). ALDARA®, Maxair®, Autohaler®, Atopiclair®, and Estrasorb® are trademarks owned by or licensed to Graceway. For more information on Graceway's products, including important safety information, please visit www.gracewaypharma.com Reference: van Seters M, van Beurden M, ten Kate FJW, Beckmann I, Ewing PC, Eijkemans MJC, et al. Treatment of vulvar intraepithelial neoplasia with topical imiquimod. N Engl J Med. 2008;358(14):1465-1473. Contact: James Lee, MD, PhD Chief Medical Officer Graceway Pharmaceuticals, LLC 800-328-0255