“Treatment of early signs and symptoms of recurrent herpes labialis
(cold sores) to reduce the progression of cold sore episodes to
ulcerative lesions in immunocompetent adults and adolescents (12 years
of age and older)”
Medivir:
The Swedish Medical Products Agency has now approved Xerclear™ for
treatment of cold sores. It is the first and only topical treatment that
has been demonstrated to prevent the incidence of cold sores and shorten
healing-times. Xerclear™ will be available from pharmacies in the first
half-year 2010.
One in four Swedes are regularly affected by cold sores (herpes
labialis). Current therapies shorten healing-times but have not been
clinically demonstrated to be able to prevent the incidence of cold
sores.
“Xerclear™ has two active ingredients with antiviral and
anti-inflammatory effects. With early treatment onset, many people can
completely avoid herpes cold sores. Xerclear™ is a completely new
concept for treating labial herpes, which has also been demonstrated to
have a far superior therapeutic effect for patients. If the occurrence
of cold sores can be prevented, this is obviously a great relief for
patients with repeated labial herpes,” commented Johan Harmenberg, MD,
Associate Professor of Virology and one of the originators of Xerclear™
Earlier this year, Xerclear™ (acyclovir 50 mg/g + hydrocortisone 10
mg/g) was approved in the US and Europe. The Swedish Medical Products
Agency has now issued its final statement of opinion, implying that
Xerclear™ will be released in Sweden, with 5g tubes available on
prescription in the first quarter of 2010. The over-the-counter 2g tube
will be available in the second quarter of 2010. The label reads:
“Treatment of early signs and symptoms of recurrent herpes labialis
(cold sores) to reduce the progression of cold sore episodes to
ulcerative lesions in immunocompetent adults and adolescents (12 years
of age and older)”.
None of the pharmaceuticals to treat herpes cold sores currently
available on the market, over-the-counter or on prescription have the
corresponding label, indicating that the incidence of a cold sore
outbreak can be prevented with early treatment onset.