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FDA Approves Zyclara for Treatment of Genital Warts


Graceway Pharmaceuticals of Bristol, Tennessee has announced that the US Food and Drug Administration has approved Zyclara cream (Imiquimod Topical) for the treatment of external gential and perianal warts (EGW) in patients 12 years of age and older. Zyclara is also approved for the treatment of actinic keratosis, a precancerous condition of the skin.

Zyclara Increases Immune System Activity

Genital warts, a type of sexually transmitted disease (STD), are caused by the human Papilloma virus. These appear as a small bump or groups of bumps in the genital area within weeks or months after sexual contact with an infected partner.

Read: Most Young Adults in New Sexual Relationships have HPV

Most currently available prescription medications for EGW are associated with lengthy treatment regimens. Zyclara Cream was developed to meet the need for a shorter regimen, while still safely and effectively clearing the warts.

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Zyclara cream belongs to a class of medications known as immune response modifiers. The medication works by increasing the body’s immune response.

Read: HPV Vaccine Offers Strong Protection from Genital Warts

In two Phase III clinical trials of imiquimod 3.75% cream, complete clearance of all warts was achieved in 28.3% of patients, compared to 9.45 on a placebo cream. Only 15% of patients treated with Zyclara Cream experienced a recurrence of their warts within 12 weeks. Efficacy was greater in females than males for all primary and secondary measurements, according to Graceway Pharmaceuticals announcement.

The most frequently reported adverse events were local skin and application site reactions. Overall, less than 1% of patients treated with Zyclara Cream discontinued its use due to adverse reactions, including redness, swelling, sores or blisters, and draining (weeping). Sexual contact should be avoided while Zyclara cream is on the skin. It is also noted that Zyclara Cream may weaken condoms and diaphragms.

For more information about Zyclara, ask your healthcare provider or visit www.zyclaracream.com.