FDA Approves Graceway Pharmaceuticals, LLC's Zyclara(R) (imiquimod) Cream, 2.5% for the Treatment of Actinic Keratoses

BRISTOL, Tenn.--(BUSINESS WIRE)-- Graceway Pharmaceuticals, LLC (Graceway) announced today that the Food and Drug Administration (FDA) has approved Zyclara® Cream, 2.5% for the treatment of actinic keratoses, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK). The new formulation may be used on the full face or balding scalp in a convenient 6-week dosing cycle.

“The addition of a 2.5% formulation of Zyclara Cream will provide healthcare practitioners greater flexibility when prescribing imiquimod therapy for patients with actinic keratoses,” said Dr. Darrell S. Rigel, a clinical professor of dermatology at New York University Medical Center and a former president of the American Academy of Dermatology. “The lower concentration offers greater tolerability while maintaining the efficacy that has long been associated with imiquimod.”

The clinical studies conducted with the 2.5% strength imiquimod formulation were intended to evaluate the efficacy and safety in the treatment for AK lesions on large areas of skin (greater than 25 cm2), full face or balding scalp. Of the four double-blind studies conducted to evaluate imiquimod 2.5% or 3.75% versus placebo, patients applying imiquimod 2.5% on a two weeks on, two weeks off, two weeks on dosing cycle experienced the least amount of local skin reactions from any of the treatment groups. In addition, 31 percent of patients using imiquimod 2.5% cream had complete clearance of AKs versus 6 percent for the placebo group.

Local skin reactions such as erythema are consistent with treatment response. Reported severe local skin reactions with the 2.5% concentration during the two-week treatment cycle regimen were notably less than the currently available 3.75% concentration: erythema (14% versus 25%), scabbing/crusting (9% versus 14%), ulceration (9% versus 11%), and flaking/scaling/dryness (4% versus 8%).

“I am excited about the addition of the new 2.5% strength to the arsenal of tools available to treat AK. The 2.5% strength treatment regimen maintains excellent efficacy with less skin reactions than the 3.75% strength. This represents a significant new treatment for AK in patients who are primarily concerned about irritation,” said Jefferson J. Gregory, Chairman and CEO of Graceway.

It is estimated that about 10 million Americans have AK, a common pre-cancerous lesion that often develops on skin frequently exposed to the sun. AKs are considered pre-cancers and could develop into a serious form of skin cancer called squamous cell carcinoma that if left unchecked can spread to other areas of the body and organs.

About Zyclara®

Zyclara Cream is a prescription medicine for topical use on the face or balding scalp to treat actinic keratoses (AK) in a 2.5% strength formulation and a 3.75% strength formulation. Zyclara 3.75% Cream is also indicated for the treatment of external genital warts. Do not use Zyclara cream in or on your eyes, nostrils, mouth or vagina.

When using Zyclara Cream, the most common side effects involve skin reactions in the application area. These include redness, scabbing or crusting, flaking, scaling or dryness, swelling, sores or blisters, and draining (weeping).

When using Zyclara Cream do not use sunlamps or tanning beds, and avoid sunlight as much as possible. Use sunscreen and wear protective clothing if you go outside during daylight.

For more information on Zyclara, visit www.ZyclaraCream.com.

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 Zyclara™ (imiquimod) Cream, 3.75%, Aldara® (imiquimod) Cream, 5%, Maxair®Autohaler® (pirbuterol acetate inhalation aerosol), Atopiclair® Nonsteroidal Cream, and Estrasorb® (estradiol topical emulsion). Zyclara™, 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.


Swanson N, Rosen T, Berman B, et al. Optimizing Imiquimod for Treating Actinic Keratosis of the Full Face or Balding Scalp: Imiquimod 2.5% and 3.75% Applied Daily for two 2-week or 3-week cycles. Poster presented at: The 12th World Congress on Cancers of the Skin in Tel Aviv, Israel, May 3-5, 2009.


Graceway Pharmaceuticals, LLCMike Nordsiek, 267-948-0402Chief Scientific Officer

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