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.
For more information, please visit www.zyclaracream.com.