Miconazole single dose is effective and safe to treat candidiasis in HIV patients: BioAlliance Pharma

Clotrimazole, current treatment against oral candidiasis is administered five times a day

Miconazole (Lauriad) is found safe and effective in treating oropharyngeal candidiasis (OPC) in HIV positive patients, said BioAlliance Pharma SA.

A pivotal Phase III study with miconazole (Lauriad) mucoadhesive buccal tablets (MBT) has found the anti-fungal drug is as effective and safe as that of clotrimazole troches  for oropharyngeal candidiasis (OPC), in HIV positive patients.

Miconazole (Lauriad) clinical studies were conducted in 40 sites in the United States, Canada and South Africa.

Miconazole (Lauriad) phase III data also demonstrated a good patient compliance as a result of the added convenience of a once-a-day dosing.

Once-daily dosage gives a superior edge miconazole (Lauriad) because the currently available treatment clotrimazole is administered five times per day in for oropharyngeal candidiasis (OPC), in HIV positive patients.

Miconazole (Lauriad) or (Loramyc) is indicated for the treatment of oropharyngeal candidiasis in immune compromised patients.

Oropharyngeal candidiasis, an opportunistic infection in fragile patients, is caused by candida, a fungus that invades the oral cavity, potentially endangering the life of a fragile patient because of its invasive risks.

Oropharyngeal candidiasis, also known as thrush, is an oral fungal infection most common in individuals with weakened immune systems – particularly those with HIV/AIDS and those undergoing cancer treatments.

Oropharyngeal candidiasis is a disruptive condition that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, burning and/or altered taste.

For cancer patients who have undergone chemotherapy or radiotherapy that has damaged the oral mucous membrane, for patients infected with HIV, for old people who are immune compromised and patients taking corticosteroids on a long-term course of treatment or taking immune suppressive treatments, the fragile environment helps the opportunistic candida fungus to proliferate.

Miconazole (Lauriad) or (Loramyc) mucoadhesive gingival tablet is the first product developed and sold by BioAlliance Pharma.

Miconazole (Lauriad) or (Loramyc) has been on the market in France since September 2007. Market launches in the rest of Europe began mid-2008 in the United Kingdom, Germany and Denmark and are set to continue in 2008 and 2009.

BioAlliance Pharma is planning to file marketing authorization applications for miconazole (Lauriad) in the United States, Korea and China.

Loramyc is based on the Lauriad technology, an oral delivery system allowing for a novel way of targeting the mucous membranes, releasing rapidly and on a continued basis a quantity of active pharmaceutical ingredient that impregnates the infected tissues, without systemic transfer. Loramyc is the first anti-mycosis specialty to use this adhesive gingival technology.

Miconazole gingival tablet has been designed to remain in place in the oral cavity  where it gradually releases the active pharmaceutical ingredient. The gingival tablet disintegrates when release has ended. The tablet matrix, which gives the tablet its mucoadhesive properties, consists of a milk protein concentrate. This natural protein excipient gradually becomes hydrated and sticks to the proteins of the mucous surface, and then releases the active pharmaceutical ingredient on a prolonged basis. This excipient has been chosen for its long-lasting adhesive qualities, and it is moreover widely used in the food industry.

BioAlliance Pharma has presented the data at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia.

IDSA represents physicians, scientists and other health care professionals who specialize in infectious diseases.

BioAlliance Pharma is a company which develops and markets innovative products in France, especially in the fields of opportunistic infections and chemotherapy complications.