Denavir FAQ

Is Denavir effective?

Denavir has been shown to shorten the duration of lesions and the duration of lesion pain. In 2 clinical studies, patients began treatment within 1 hour of symptom onset, and continued treating for 4 days, applying product every 2 hours during waking hours.⁴

• The mean duration of herpes lesions was approximately one half-day shorter in the subjects treated with Denavir compared with placebo/vehicle. (4.5 d with Denavir vs. 5 d with placebo/vehicle.)
• The mean duration of lesion pain was also approximately one half-day shorter with Denavir compared with placebo/vehicle.

What are the side effects of Denavir?

Denavir was generally well tolerated in clinical trials. In clinical studies, the most common adverse reaction with Denavir was headache, which occurred in 5.3% of patients who received Denavir and 5.8% of patients who received placebo/vehicle.⁴

Other adverse reactions with Denavir occurred in <2% of patients and included application site reaction, decreased sensitivity to touch/local anesthesia, taste perversion, and rash.⁴

I prefer oral antivirals for cold sores. Why should I prescribe Denavir?

Denavir has the same trusted mechanism of action as oral antivirals; it selectively targets cells infected with HSV-1 and inhibits viral DNA replication.^{† 4,5}

Denavir has the following characteristics.

• Denavir has been shown to reduce lesion duration and the duration of lesion pain.⁴
• Denavir is a topical cream that provides relief from discomfort, dryness, and cracking.^2,4
• Denavir has a broad treatment window — it can be initiated during the prodrome or when lesions appear.⁴
• As a topical cream antiviral, Denavir penetrates the skin at the application site to inhibit viral replication.^{† 4,5}
• Denavir is a topical cream that has not been shown to be systemically absorbed in adults.^{‡ 4}
• Unlike oral antivirals, Denavir does not require dosing adjustments for patients with renal impairment.⁴

What is the dosing for Denavir?

Denavir should be applied every 2 hours during waking hours for 4 days.⁴

When possible, treatment with Denavir should be initiated at the first sign or symptom of a cold sore. However, unlike some other prescription and over-the-counter cold sore medicines, Denavir may also be initiated when the lesion has formed.⁴

Has the formulation for Denavir changed?

No, the formulation Denavir remains unchanged. It is a topical cream containing the active ingredient penciclovir.⁴ New American Therapeutics, Inc. is now marketing Denavir and providing comprehensive support and customer service.

What is managed care coverage like for Denavir?

Denavir has strong managed care coverage. Over 93% of commercial managed care and Medicare plans provide unrestricted access to Denavir. It is covered in tiers 2 and 3 in most commercial, Medicare, and Medicaid plans.

^† In in vitro studies.
^‡ The systemic absorption of penciclovir following topical administration has not been evaluated in patients <18 years of age.

Denavir History

Did you know that Denavir^® (penciclovir cream, 1%) has been shortening the duration of cold sores for longer than any other prescription cold sore cream in the U.S.? Denavir was the first prescription antiviral cream approved for the treatment of recurrent cold sores.⁴ It targets cells that are infected with HSV-1, the virus that causes cold sores.^{† 4,5}

Since 1996, Denavir has consistently provided relief for recurrent cold sores in adults and children 12 years of age and older.⁴

Denavir is distributed by New American Therapeutics, Inc. A new kind of pharmaceutical company, New American Therapeutics focuses on patient care and strives to make effective therapeutics work even better for patients.

Learn a little more about us.

^† Denavir selectively targets cells infected with HSV-1 and prevents the virus from reproducing.