Profounda announced the launch of Impavido (miltefosine) for the treatment of visceral, mucosal, and cutaneous leishmaniasis in patients aged ≥12 years. Currently, there are no other approved drugs for the treatment of cutaneous or mucosal leishmaniasis.

Leishmaniasis is a parasitic disease spread by the bite of phlebotamine sand flies. There are several different forms of the disease, with the most common being cutaneous leishmaniasis, which causes skin sores. Visceral leishmaniasis affects several internal organs and can be life-threatening; typical symptoms include fever, weight loss, enlargement of the spleen and liver, anemia, leukopenia, and thrombocytopenia. A less common form of the disease is mucosal leishmaniasis, which can occur when the infection spreads from the skin to the mucous membranes, causing sores in the nose, mouth, or throat.

Impavido was initially approved by the Food and Drug Administration (FDA) in March 2014 based on data from four safety and efficacy clinical trials. It was later granted Fast Track designation, Priority Review, and Orphan Product designation.

RELATED: FDA Approves First Cutaneous, Mucosal Leishmaniasis Drug

Impavido is an alkyllysophospholipid analog drug and its specific mode of action against Leishmania species is not known. It is believed to exert its action through interaction with lipids (phospholipids and sterols), including membrane lipids, inhibition of cytochrome c oxidase, and apoptosis-like cell death. The drug has demonstrated anti-leishmanial activity in vitro and in clinical infections.

The labeling for Impavido includes a boxed warning to alert patients and healthcare professionals that the drug can cause fetal harm and therefore should not be given to pregnant women.  The most common side effects identified in clinical trials were nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, itching, drowsiness and elevated transaminases and creatinine.

Impavido is available as 50mg capsules in 14-count blister cards.

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